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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 37601
Device Problems Premature Discharge of Battery ; Failure to Deliver Energy ; No Device Output ; Low impedance; Device Operates Differently Than Expected
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no significant anomaly. The ins was at normal end of life and telemetry and output were okay.

 
Event Description

Additional information received from a consumer reported the implantable neurostimulator (ins) lasted 13 months and they had two shorts. The consumer thought the shorts were in the connections up to their head and the fix would be replacing the leads. The consumer would rather work with what they have than replace the leads, but they were going to meet with their health care provider (hcp) in a week. A manufacturing representative was there when the ins was replaced and the patient talked to them about the shorts. The consumer stated they decided not to use the two shorts.

 
Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7482a95, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description

It was reported that the patient saw a ¿call you doctor¿ end of service (eos) message on his programmer. He saw the message on the day of the report and was unable to adjust stimulation or get it to turn on. The patient experienced a sudden loss of therapeutic effect and stimulation. His left hand started shaking, so he grabbed the programmer to check the status and saw the message. Follow-up from the healthcare provider (hcp) reported that there was not 50% or greater symptom reduction. Reprogramming was not needed as the event was due to end of battery life. It was later reported to be premature battery depletion. Impedance testing was done and the ins showed a short on contact 1 and 3. The patient was reprogrammed in (b)(6) to these parameters and this may have been the cause of early depletion. The ins was replaced. Follow-up from the patient reported that he did have concerns with his device or therapy. The patient wanted to know why the ins had a shortage and did not last as long as the last one. This led to the patient questioning how long the new ins would last. However, he noted that new ins worked fine.

 
Manufacturer Narrative

 
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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 Key4143638
Report Number3004209178-2014-18325
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 09/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/14/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2012
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: 10/06/2014 Patient Sequence Number: 1
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