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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type  Injury  
Event Description

It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information reported that a healthcare professional (hcp) involved with the event "thought that the (lead) deviation might have been caused by a bent stylet tip. ".

 
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Brand NameUNKNOWN IMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4850234
Report Number3007566237-2015-01677
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/09/2015
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/17/2015 Patient Sequence Number: 1
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