PATIENT CABLE
Received Dec 17, 2024
Report 2182208-2024-05335 · MDR key 20951862
Device
Generic name
Cable, Transducer And Electrode, Patient, (inc
Manufacturer
Medtronic, Inc.Model number
5492ALCatalog number
5492AL
Lot number
2208067
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT CABLE CONNECTOR WAS LOOSE LEADING TO NO PACING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PATIENT CABLE CONNECTOR WAS LOOSE LEADING TO NO PACING. THE CABLE PASSED ALL VISUAL INCOMING INSPECTION WITH NO ANOMALIES FOUND. ALL CONTINUITY TESTS PASSED, NO INTERMITTENT OR SHORTED CONNECTIONS FOUND MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.