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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 Material Separation
Event Date 06/08/2016
Event Type  Malfunction  
Manufacturer Narrative

The device serial number was requested, but was not provided. Without this information, the device manufacturing date and device expiration date may not be obtained. 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.

 
Event Description

Medtronic received information that during implant of this temporary lead, a portion of the lead became stuck in the small space between the proximal electrode and the wire. No separation was observed on the returned device. No adverse patient effects were reported.

 
Manufacturer Narrative

Conclusion: upon receipt at medtronic's quality laboratory, no lot number was identified. A review of the device history record associated with this event cannot be performed. The event was confirmed: the gap between the outer insulation and the electrode ring was 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 instructions for use [(b)(4)] indicates that [additional stretching of the blue monofilament coil is not required. Do not overstretch the coiled portion of the blue monofilament coil. ]. 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 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 Key5771256
Report Number2025587-2016-00980
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
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 Received07/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6495J
Device Catalogue Number6495J
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/17/2016
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
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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