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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 37601
Event Date 07/20/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant: product id 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3389s-40, lot# va0uvrw, implanted: 2015-(b)(6), product type lead. Product id 3389s-40, lot# va0w5ce, implanted: 2015-(b)(6), product type lead. (b)(4).

 
Event Description

Information was received from another source that reported the patient went to see his health care professional (hcp) and was exposed to some sort of test/environment where he lost the ability to speak. There was emi environmental exposure. The patient had a loss of speech. The patient was implanted for parkinson铠dual and movement disorders. Further follow-up is being conducted to determine what steps were taken to resolve the loss of speech. If additional information is received, a follow-up report will be sent.

 
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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 Key4992995
Report Number3004209178-2015-15815
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation Other
Report Date 07/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/28/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/01/2014
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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