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

Model Number 6491F

Device Problems Fracture (1260); Material Fragmentation (1261); No Pacing (3268)

Patient Problem No Information (3190)

Event Date 06/08/2020

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 4 days post implant of this temporary pacing lead, the pacing function did not work.Therefore, a spare lead was used to provide pacing.Five days post implant of the original lead, x-ray showed a possible fracture of the lead.Ultimately, 13 days post implant, the lead was removed.It was reported that a portion of the lead tip, approximately 5mm long, remained in the patient.No additional adverse patient effects were reported and there is no plan for re-intervention at this time.

Manufacturer Narrative

Conclusions: the device history record was reviewed and showed that this lot of products met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.While no root cause had been identified for the fracture, the fracture most probably occurred due to fatigue related to flexing with the distal electrode in combination with, but not limited to, the position of the electrode in the heart tissue, patient tissue condition, dislodgement, or implant technique.Lead fracture is a known potential complication of temporary pacing leads listed in the instructions for use (ifu).E1: facility name corrected.G5: pma / 510(k) # corrected 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: MEDTRONIC
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10256193
• MDR Text Key: 198308714
• Report Number: 2025587-2020-02196
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K012454
• 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: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6491F
• Device Catalogue Number: 6491F
• Device Lot Number: BAB135206P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO