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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR TEMPORARY ATRIAL PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY

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MEDTRONIC, INC. UNIPOLAR TEMPORARY ATRIAL PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6492
Device Problems Material Fragmentation; Physical Resistance
Event Date 05/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: the product specimen has been received; however, this device evaluation is in progress. Conclusion: should additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that while removing this temporary pacing lead from the patient 6 days post implant, there was significant resistance and the lead broke, leaving a part of the lead in the patient. No intervention was performed and no adverse patient effects were reported. It is unknown how many days the lead was implanted.

 
Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the two pieces of products were received tightly knotted together, most likely during operating surgery. The distal stainless electrode and a piece of blue monofilament coil which provides fixation while the lead is implanted were missing from both products. The inspection after decontamination of the two broken leads indicated that the fractured conductor wire appeared irregular, most likely due to fatigue and elongation stress. These products have been submitted to severe handling, most likely at the implant procedure. This is not recommended by the instruction for use of this device. No root cause for the fracture had been identified or can be assigned to a manufacturing issue. Conclusion: 3 products were returned, 2 broken pieces and one sterile not used product. The event is confirmed on the two broken pieces of lead. The inspection of the non-used product confirmed that the returned product of the same batch (bbd027206f) is conforming to design specifications. A review of the device history record of batch (bbd027206f) associated with this event had been performed without identifying any potential of a manufacturing issue. The inspection of the two broken leads indicates that the fractured conductor wires appear irregular, most likely due to fatigue and elongation stress. These products have been submitted to severe handling, most likely at the implant procedure (two tight knots and loops had been applied to the two lead bodies). Although the instruction for use indicates that the physician may choose to vary the lead fixation procedure in accordance with judgment and experiences, the selected fixation method should always allow for later pacing lead removal. It also indicates in the lead handling section to not excessively bend, kink, twist, or stretch the pacing lead. Excessive bending, kinking, twisting or stretching may damage the junctions, pacing lead body and insulation resulting in device failure and / or loss of therapy. No root cause had been identified for the fracture, other items may have affected the performance of the 6492 like, but not limited to: location of implant, patient tissue condition, loss of implant location, the implant technique, etc. There is no trend for this event type. In the past 5 years no fracture issue had been reported with unipolar temporary atrial pacing lead model 6492. 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.

 
Manufacturer Narrative

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

 
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Brand NameUNIPOLAR TEMPORARY ATRIAL PACING LEAD
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway, ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC, INC.
710 medtronic parkway, ne
minneapolis MN 55432
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key5710289
Report Number3008592544-2016-00039
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6492
Device Catalogue Number6492
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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