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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 Type  Injury  
Event Description

It was reported that when the patient¿s second side was started, their moth froze and they were not able to talk. The lead was taken out and implant had to be rescheduled. The patient stated that they were only able to put one side in, not both, and they had to go back twice in surgery to put the other side in. The patient further stated someone was being sent out today, but they were not sure if it was a nurse or manufacturing representative. Follow up with the patient indicated that they did not have concerns with their device or therapy.

 
Manufacturer Narrative

Concomitant: product id 37603, serial# (b)(4), implanted: 2015-(b)(6), product type implantable neurostimulator. Product id 3708640, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3387s-40, lot# va0kc0b, implanted: 2015-(b)(6), product type lead. Product id 37642, serial# (b)(4), product type programmer, patient. (b)(4).

 
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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 Key4592156
Report Number3007566237-2015-00584
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 02/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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? No
Date Manufacturer Received02/18/2015
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: 03/11/2015 Patient Sequence Number: 1
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