MAUDE Adverse Event Report: MEDTRONIC, INC. SCREW-IN TEMPORARY LEAD ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6416

Device Problems Pacing Problem; Device Dislodged or Dislocated

Event Date 05/01/2003

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers. Patient information is limited due to confidentiality concerns. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿utility and safety of prolonged temporary transvenous pacing using an active-fixation lead: comparison with a conventional lead. ¿ pace 2003; 26:1245¿1248.

Event Description

A journal article was reviewed that contained information regarding this temporary pacing lead model. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided. The article indicated that there were patients with infection, venous thrombosis ¿inappropriate sensing,¿ and dislocations. The status/location of the lead is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.

• Brand Name: SCREW-IN TEMPORARY LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view , MN 55112 ; 7635052036
• MDR Report Key: 6924124
• Report Number: 2182208-2017-01672
• Device Sequence Number: 1
• Product Code: LDF
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,L

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/01/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/06/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 6416
• Device Catalogue Number: 6416
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial