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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6495J
Device Problem Sticking
Event Date 07/25/2016
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: the product specimen has been received for analysis; however, device evaluation is currently in progress. Conclusion: upon completion of device evaluation, a supplemental report will be submitted.

 
Event Description

Medtronic received information that during the use of this temporary pacing lead, a portion of the lead became stuck to the myocardium on a small gap between the proximal electrode and blue line. No additional intervention and no adverse patient effects were reported.

 
Manufacturer Narrative

Analysis: a product was returned for analysis, with several pictures of the device provided for review, but no lot number was identified. Without the lot number, a review of the device history record associated with this event cannot be performed. There was a gap between the outer insulation and the electrode ring. This was caused by the outer blue insulation, which slides back on the conductor wire. On the returned product, that gap exposed a 1 mm gap between the blue insulation and outer conductor wire, well within design specifications. This situation may be slightly different than the situation observed after product implant, as the blue insulation slid easily on the conductor wire, at the time of the product analysis. This 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 and / or subsequent handling. During implant clamping the blue lead body conductor wire and then pulling on the monofilament may result in such situation, too. The product instructions for use state that ¿additional stretching of the blue monofilament coil is not required. Do not overstretch the coiled portion of the blue monofilament coil. ¿ conclusion: the review of the returned product confirms the product shows up within the design requirement. The distal side of the returned product may have received some abnormal stress which may have result in the situation observed. 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.

 
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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 Key5877077
Report Number2025587-2016-01249
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 Received08/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6495J
Device Catalogue Number6495J
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2016
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? 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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