KAPPA 900 DR
Received Dec 9, 2016 · Event occurred Sep 26, 2016
Report 2647346-2016-00031 · MDR key 6162477
Device
Generic name
Pulse-generator, Pacemaker, Implantable
Manufacturer
Medtronic Puerto Rico Operations Co., HumacaoModel number
KDR901Catalog number
KDR901
Product problems
- Failure to Interrogate
- Failure to Interrogate
Patient
28 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO INTERROGATE THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG), EVEN USING TWO DIFFERENT PROGRAMMERS. NO ADDITIONAL INFORMATION COULD BE OBTAINED AFTER SEVERAL FOLLOW-UP ATTEMPTS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.