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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 the patient ¿seemed sleepy, struggled to open his eyes,¿ had slowed and mumbled speech, and increased tremor frequency and severity. The patient was ¿in intensive care¿ at the time of report. The patient¿s physician indicated ¿the patient had a hemorrhage at the lead tip and at the entry point of the lead. ¿ it was unknown when the event had occurred; however, the issue was noted to have been found on a post-operative ct scan that was performed either the afternoon of or morning after implant. It was noted there were ¿no vessels¿ found during ¿stealth¿ imagine in either location. The cause of the issue remained undetermined at the time of report. The patient was alive ¿with injury¿ and had ¿no improvement¿ in their symptoms at the time of initial report. Some reprogramming was performed with the patient as a result, though ¿no clinically significant benefit¿ had been attained as of three days after initial report. The patient was ¿unwell¿ and continued to have ¿slurred speech, poor eyes, and bad tremor¿ as of three days after initial report. It was stated the ¿true benefit was unknown¿ at that time. It was "unknown" whether any interventions had been required due to the event. Additional information was requested; a supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Concomitant product: product id 3389-40, lot # va0pc08, implanted: (b)(6) 2015, product type lead. (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 Key4749095
Report Number3007566237-2015-01205
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2015
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? Yes
Date Manufacturer Received04/15/2015
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: 05/05/2015 Patient Sequence Number: 1
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