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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 the patient¿s second deep brain stimulator was never turned on because there was a short in the wire. The device had never worked, it had shorted out. The patient had suffered with stroke like symptoms and headaches for years. The patient¿s daughter had received a phone call from the retirement home where the patient lived informing her that the patient had seemed to be having a stroke, they could not make sense of patient¿s communication, patient had a drooping face on one side and patient had gone to the hospital which had been about 2-3 years prior to the date of this report. At the hospital a test was done and they could not find anything wrong. The drooping face, unable to make sense of communication and could not find things had continued for about 6 weeks. The patient had seen her cardiologist who was unable to get a read on her pacemaker and thought it was the deep brain stimulator impacting the pacemaker reading, there was interference with the deep brain stimulator therapy. The patient noted that that could not happen since the deep brain stimulator was never turned on. A manufacturing representative checked the deep brain stimulator implant and found it to be on and causing all the symptoms the whole time. It was unknown how the device was turned on. The patient had headaches around lead area on the head. They had gone ahead and snipped the wires, removed the harness, and turned the device off. This had relieved headaches. The patient had had pretty debilitating symptoms from the device. The implantable neurostimulator (ins) and wires were still implanted but were disconnected so the ins could not be turned on. The patient had not had the relief she should have.

 
Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead. Product id: neu_unknown_ext, serial# unknown, product type: extension. (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 Key4888403
Report Number3007566237-2015-01852
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2015
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
Date Manufacturer Received06/08/2015
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: 07/02/2015 Patient Sequence Number: 1
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