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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM MHY/GZF/GZB

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MEDTRONIC NEUROMODULATION INTERSTIM MHY/GZF/GZB Back to Search Results
Model Number 3625
Device Problems Device Damaged by Another Device; Lead
Event Date 07/15/2009
Event Type  Malfunction  
Event Description

During a stage ii implant, there was difficulty removing the stage i lead from the ipg. The lead was protruding from the screw holes in the percutaneous extension. All of the screws were removed and the lead was found to be damaged. A new lead was placed, but the results were not the same as the previous lead. Pt was reported to have leg pain and no therapeutic benefit. The hcp is scheduled to place a new lead.

 
Manufacturer Narrative

(b) (4).

 
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Brand NameINTERSTIM
Type of DeviceMHY/GZF/GZB
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1492214
Report Number2182207-2009-05859
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/22/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number3625
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/22/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/20/2009 Patient Sequence Number: 1
Treatment
IMPLANTED:
EXPLANTED:
IMPLANTED:
LEAD: MODEL 3093, LOT# V266475,
EXPLANTED:
EXTENSION: MODEL PERC EXT, LOT# UNK,
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