CLAVIS EMG/STIM DEVICE

Description of Event or Problem

PART 9015A0012 - CLAVIS EMG/STIM DEVICE. DURING A REVIEW OF A LITERATURE REPORT (J REHABIL MED 2023; 55: JRM11963 RESULTS PAGE 4). WITH REFERENCE TO EFFECTIVENESS OF ULTRASOUND-GUIDED VS ELECTRICAL-STIMULATIONGUIDED BOTULINUM TOXIN INJECTIONS IN TRICEPS SURAE SPASTICITY AFTERSTROKE: A RANDOMIZED CONTROLLED STUDY, THE FOLLOWING INFORMATION WAS DOCUMENTED: WOUND ON THE OUTSIDE OF THE ANKLE - LINKED TO A CONFLICT WITH A SPLINT, IS MORE RELATED TO THE RECURRENCE OF SPASTICITY.

Additional Manufacturer Narrative

FOLLOW UP 001 REF NATUS COMPLAINT# (B)(4). IT WAS CONFIRMED THAT THIS EVENT WAS NOT RELATED TO THE DANTEC CLAVIS DEVICE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AS THE STUDY AUTHOR CONFIRMED THAT THE ADVERSE EFFECTS NOTED WERE NOT DUE TO THE DANTEC CLAVIS DEVICE. A DEVICE HISTORY RECORD REVIEW IS NOT APPLICABLE AS THE AUTHOR OF THE STUDY CONFIRMED THAT THE DANTEC CLAVIS DEVICE DID NOT MALFUNCTION OR CAUSE THE ADVERSE EVENT. NO SERIAL NUMBER WAS PROVIDED BY THE STUDY AUTHOR AS THEY CONFIRMED THE ADVERSE EFFECTS NOTED WERE NOT DUE TO A MALFUNCTION OF THE DANTEC CLAVIS DEVICE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC-(B)(4). FAILLURE CONFIRMED: NO ,= INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE.

Description of Event or Problem

PART 9015A0012 - CLAVIS EMG/STIM DEVICE. DURING A REVIEW OF A LITERATURE REPORT (J REHABIL MED 2023; 55: JRM11963 RESULTS PAGE 4). WITH REFERENCE TO EFFECTIVENESS OF ULTRASOUND-GUIDED VS ELECTRICAL-STIMULATIONGUIDED BOTULINUM TOXIN INJECTIONS IN TRICEPS SURAE SPASTICITY AFTERSTROKE: A RANDOMIZED CONTROLLED STUDY, THE FOLLOWING INFORMATION WAS DOCUMENTED: WOUND ON THE OUTSIDE OF THE ANKLE - LINKED TO A CONFLICT WITH A SPLINT, IS MORE RELATED TO THE RECURRENCE OF SPASTICITY.

Additional Manufacturer Narrative

INITIAL REPORT (REF NATUS COMPLAINT #(B)(4)). NATUS TO REACH OUT FOR FURTHER INFORMATION TO ENSURE ALL RELATED DETAILS ARE RECEIVED AND DOCUMENT. LOT / SERIAL NUMBER TO BE CONFIRMED. THE REPORT WAS WRITTEN BY: ISABELLE HAURET, MD, MSC1, LECH DOBIJA, PT, MSC1, PASCALE GIVRON, MD1, ANNA GOLDSTEIN, MD, MSC1, BRUNO PEREIRA, PHD2 AND EMMANUEL COUDEYRE, MD, PHD1. FROM THE 1DEPARTEMENT OF PHYSICAL AND REHABILITATION MEDICINE, CLERMONT-FERRAND UNIVERSITY HOSPITAL, CLERMONT AUVERGNE UNIVERSITY, INSTITUT NATIONAL DE RECHERCHE AGRONONOMIQUE ET ENVIRONNEMENT, FRANCE AND 2INNOVATION AND CLINICAL RESEARCH, CLERMONT-FERRAND UNIVERSITY HOSPITAL, CLERMONT-FERRAND, FRANCE.

Additional Manufacturer Narrative

FOLLOW UP 002 REF NATUS COMPLAINT# (B)(4). CORRECTION TO SECTION D - UDI RELATED DATA QUALITY UPDATES ONLY.

Description of Event or Problem

PART 9015A0012 - CLAVIS EMG/STIM DEVICE. DURING A REVIEW OF A LITERATURE REPORT (J REHABIL MED 2023; 55: JRM11963 RESULTS PAGE 4). WITH REFERENCE TO EFFECTIVENESS OF ULTRASOUND-GUIDED VS ELECTRICAL-STIMULATIONGUIDED BOTULINUM TOXIN INJECTIONS IN TRICEPS SURAE SPASTICITY AFTERSTROKE: A RANDOMIZED CONTROLLED STUDY, THE FOLLOWING INFORMATION WAS DOCUMENTED: WOUND ON THE OUTSIDE OF THE ANKLE - LINKED TO A CONFLICT WITH A SPLINT, IS MORE RELATED TO THE RECURRENCE OF SPASTICITY.