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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Event Date 03/25/2015
Event Type  Injury  
Event Description

It was reported that the patient¿s neurologist called the manufacturer representative (rep) and asked which x-rays would provide the best image of the implantable neurostimulator (ins), extensions, and leads. The patient self-admitted to the emergency room (er) the morning of the report; he had pain on the right side of the neck and a return of symptoms, including speech degradation and a change in gait. It was considered a sudden loss of stimulation and therapeutic effect. The ins was checked by the neurologist using a clinician programmer and it appeared to be on without any problems. The patient was hospitalized due to the event and was referred back to the original implanting physician for evaluation. No surgical interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

 
Manufacturer Narrative

Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 64002, lot # n248030, implanted: (b)(6) 2010, product type adapter; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
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 Key4693815
Report Number3004209178-2015-07264
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2011
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/25/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/30/2010
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: 04/15/2015 Patient Sequence Number: 1
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