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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 Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Event Description

It was originally reported on (b)(6) 2013 the patient was having program issues with their gait and ability to start walking. The reporter stated they wanted to know if there was a deep brain stimulation data base to find possible solutions for their particular issues. Additional information received reported that the implantable neurostimulator (ins) and extensions were explanted due to generator erosion. The patient recovered without sequela.

 
Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
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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 Key4953266
Report Number3004209178-2015-14368
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/09/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/04/2012
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: 07/30/2015 Patient Sequence Number: 1
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