• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION TEMPORARY PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
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.  .

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEMPORARY PACING LEAD
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key10043780
MDR Text Key190529401
Report Number2025587-2020-01605
Device Sequence Number1
Product Code LDF
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK012454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received05/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/04/2021
Device MODEL Number6491P
Device Catalogue Number6491P
Device LOT NumberBAB142206P
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/11/2020 Patient Sequence Number: 1
-
-