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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA PC

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MEDTRONIC NEUROMODULATION ACTIVA PC Back to Search Results
Model Number 37601
Device Problem Device Operates Differently Than Expected
Event Type  Injury  
Event Description

It was reported that there was a complaint about stimulation, tingling in the left leg. Impedances 0-3 measured 1015-2449 and 8-11 measured 1396-3258. Patient was programmed 1- and 2+ on left c+ and 9- on right. Stimulation was 100% used. Company representative did know that patient needed a revision, which was done. Patient was reported doing fine.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameACTIVA PC
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
anne reali
7000 central avenue ne rcw215
minneapolis , MN 55432-3568
7635269755
MDR Report Key1859008
Report Number3007566237-2010-07608
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/08/2010
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: 10/05/2010 Patient Sequence Number: 1
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