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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. SCREW-IN TEMPORARY LEAD ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
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.

 
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Brand NameSCREW-IN TEMPORARY LEAD
Type of DeviceELECTRODE, 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 Key6924124
Report Number2182208-2017-01672
Device Sequence Number1
Product CodeLDF
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
1 Patient Was Involved in the Event
Date FDA Received10/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6416
Device Catalogue Number6416
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 Received08/01/2017
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

Patient TREATMENT DATA
Date Received: 10/06/2017 Patient Sequence Number: 1
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