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

Model Number 6491P

Device Problems Material Fragmentation (1261); Off-Label Use (1494)

Patient Problem No Information (3190)

Event Date 04/27/2020

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 during the explant of this temporary pacing lead, the lead fractured.It was reported that the tip of the lead remains in the patient.No additional interventions or actions were reported.The lead used in this event had been implanted for 14 days prior to removal.This lead is intended for use no more than 7 days, and is intended to be used in a pediatric population.The patient involved in this case was (b)(6) years old.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that two leads were returned, both tied together by a knot 190mm from the distal electrode area.The conductor wire of one lead was broken at the distal side near the electrode tip area.The other lead showed no evidence of damage.Conclusions: 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.According to the instructions for use (ifu), this product is intended for pediatric temporary atrial and ventricular pacing and sensing for an implant duration of 7 days or less.The fracture most likely 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, dislodgement, the implant technique, and the 14-day implant duration.The reported information indicates that the surgeon elected to leave the wire in the patient beyond the intended use application.D10: 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: 10043780
• MDR Text Key: 190529401
• Report Number: 2025587-2020-01605
• 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: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: 6491P
• Device Catalogue Number: 6491P
• Device Lot Number: BAB142206P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR