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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 01/24/2013
Event Type  Injury  
Event Description

It was reported the patient had perioperative delirium. The suspected cause was noted as the implant/study. There was no corrective action taken and the event resolved on (b)(6) 2013.

 
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, lot# serial# unknown, product type: extension. Product id: neu_unknown_ext, lot# 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. (b)(4).

 
Event Description

Additional information reported in was unknown if the delirium and increased fatigue were related to the implant procedure or study. The suspected cause was a patient condition. All symptoms were resolved.

 
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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 Key4653387
Report Number3007566237-2015-00857
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2015
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: 04/02/2015 Patient Sequence Number: 1
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