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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 03/06/2013
Event Type  Injury  
Event Description

It was reported the patient had experiential phenomenon, depression, and illusions. No intervention was taken and the event was considered resolved.

 
Manufacturer Narrative

Concomitant 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# v9 86836, 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 the depression was not related to the device. It was unknown if the experiential phenomenon and illusions were related to the study and programming. One event of experiential phenomenon was unresolved.

 
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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 120
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 Key4658177
Report Number3007566237-2015-00870
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2013
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/18/2012
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: 04/03/2015 Patient Sequence Number: 1
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