MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION TEMPORARY PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495JP

Device Problem No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this temporary pacing lead, it did not provide proper stimulus.The lead was replaced with a different lead and the condition improved.No adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed the lead was separated from and returned without the thorax needle.Visual inspection revealed the lead body was severely damaged.The electrical test results showed electrical resistance and intermittency met design specifications.The lead did not pass the dielectric withstanding voltage test and showed a short circuit between both inner and outer conductor wires due to damages on the conductor wire.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The failure of the device related to the reported event has been identified and is associated with severe damage of the conductor wire lead body.Such a situation is not result of manufacturing activities.The root cause of the issue is most probably the result of the handling of the product during the operation.The instructions for use (ifu) for this product model indicates as precautions that ¿excessive bending, kinking, twisting or stretching may damage the junctions, pacing lead body and insulation resulting in device failure and/or loss of therapy¿; provides instructions such as ¿the pacing lead in the heart is aligned with the exit from the chest.Leave an extra length of the conductor wire in the chest to prevent dislodgment during patient movement¿.The ifu also provides instructions for connection of the lead connector pins to the external pulse generator and to observe polarity designation.D9: device available for evaluation? updated h3: device evaluated? updated h6: coding updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: TEMPORARY PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11922056
• MDR Text Key: 253808933
• Report Number: 2025587-2021-01754
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K963898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 6495JP
• Device Catalogue Number: 6495JP
• Device Lot Number: CPA050204P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1