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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 parkinson¿s disease patient¿s ¿effect was stable¿ and their ¿programmer could work normally¿ following the replacement of their implantable neurostimulator (ins) on 2014-(b)(6). However, in 2014-(b)(6) the patient¿s programmer reportedly ¿couldn¿t work. ¿ furthermore, ¿the patient¿s limbs were trembling when the device was turned on. ¿ the patient¿s physician reportedly ¿judged the cause as lead disconnection. ¿ the patient¿s lead was replaced as a result. Following the lead replacement, ¿the patient¿s symptom got better and the programmer could work. ¿ it was noted the ¿patient didn¿t fall down¿ at that time. A supplemental report will be filed if additional information is received.

 
Manufacturer Narrative

Concomitant: product id 3389-40, lot# 0204990374, implanted: 2011-(b)(6), product type lead. (b)(4). Device evaluation: analysis of the lead found ¿all four conductors were broken 3. 3 cm from the proximal end of the lead. There was also breached esc (environmental stress cracking) 8. 8 and 9. 6 cm from the distal end of the lead. ¿ it was also noted that ¿all circuits were open¿ during functional testing.

 
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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 Key4325534
Report Number3007566237-2014-03608
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2014
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? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2014
Date Manufacturer Received11/25/2014
Was Device Evaluated By Manufacturer? Yes
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: 12/12/2014 Patient Sequence Number: 1
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