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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 37602
Event Type  Injury  
Event Description

It was reported that the patient had a loss of therapeutic effect. He felt a therapy ¿fall off¿ in the month prior to the report and had not had any significant falls or trauma. When he was lying on his right side his therapy would change. The manufacturer representative (rep) stated that the impedances had been ¿high¿ since implant, but then later stated they had been fine in the past. It was unclear when the impedance issues began and the actual values provided appeared to be within the normal range. The implantable neurostimulator (ins) was at end of service (eos) and the voltage showed 2. 83 volts. A longevity calculation was performed based on the patient¿s settings and noted that the battery should last five and a half years. Five days later the rep mentioned that the healthcare provider (hcp) was scheduling a replacement of the ins and extension. It was reported that a short circuit was discovered in the patient¿s system, which led to premature battery depletion.

 
Manufacturer Narrative

Concomitant medical products: product id: 7482a51, serial# (b)(4), implanted: 2007-(b)(6), product type: extension. Product id: 3387s-40, lot# v055961, implanted: 2007-(b)(6), 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 Key4672397
Report Number3004209178-2015-06230
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/19/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/10/2013
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: 04/09/2015 Patient Sequence Number: 1
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