• 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 MEDTRONIC 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 MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6495J
Device Problem Device Dislodged or Dislocated
Event Date 06/28/2016
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: the product has been returned for evaluation. Conclusion: should additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that during explant of this temporary pacing line, the device became stuck on the small gap between the proximal electrode and blue line. No adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: 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. The event is confirmed: the gap between the outer insulation and the electrode ring is caused by the outer blue insulation which slides back on the conductor wire; this may be the consequence of the handling of the lead body during manufacturing, implant procedure, implanted time on a beating heart, and / or subsequent handling. During implant clamping the blue conductor wire and then pulling on the monofilament may also result in such situation too. The reported event is unrelated to a product failure or malfunction.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC
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 Key5806581
Report Number2025587-2016-01092
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/31/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2019
Device MODEL Number6495J
Device Catalogue Number6495J
Device LOT NumberAAE060203F
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-