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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
Event Date 10/01/2014
Event Type  Injury  
Event Description

It was reported that the patient experienced myoclonic jerks of arms and legs. Corrective actions included medication added, discontinued or dose changed. Depakote was started after lab work was reviewed on (b)(6) 2014. The event was not resolved.

 
Manufacturer Narrative

Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va01k4q, product type: lead. Product id 3387s-40, lot# va 04z6f, product type: lead. Product id 3708660, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. The manufacturing site id was previously reported as #3007566237. Additional information indicates the correct manufacturing site id is 3004209178.

 
Event Description

Additional information reported it was unknown if the myoclonic jerks were related to the study and programming. The suspected cause was unknown.

 
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
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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 MN 55421 1200
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 Key4662492
Report Number3007566237-2015-00895
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2014
Device MODEL Number37601
Device Catalogue Number37601
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 Received06/13/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/08/2012
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: 04/06/2015 Patient Sequence Number: 1
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