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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Device Problem Failure to Deliver Energy
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

A consumer reported that the patient whose indication for use was parkinson¿s dual and movement disorders had had a fall on (b)(6) 2015 and broke two fingers on the right hand and starting on (b)(6) 2014 the patient had a loss of stimulation and a return of shaking. The shaking the patient was experiencing was in both legs and the right hand. It was unknown what the patient was doing when they had lost therapy. The device was checked with the patient programmer and stimulation was on. The patient does not have the ability to adjust stimulation. Follow-up is being conducted to obtain information about troubleshooting done. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

 
Event Description

Additional information received from the consumer reported the issue had been resolved. They went to see their doctor soon after they had called the manufacturer. They raised the voltage and the patient had been doing fine since. The doctor also put the patient on balance therapy and they were doing really well.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key5042386
Report Number3004209178-2015-16999
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/07/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/14/2016
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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