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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 37602
Event Date 08/06/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3389040, lot# v008653, implanted: (b)(6) 2006, product type: lead. (b)(4).

 
Event Description

A health care provider (hcp) reported an end of service (eos) error code was displayed. The right implantable neurostimulator (ins) said eos and the left ins was on and okay. The hcp stated the eos explained why the patient was leaning to their left more prominently. A day prior to this report, the patient was not swallowing as well. Usually the hcp checked the patient's inss every friday, but they were not there last friday and they were not sure if the ins were checked. The patient's indication for use is parkinson's dual and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. 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 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 Key5039417
Report Number3004209178-2015-16941
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation Health Professional
Report Date 08/07/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/28/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/10/2012
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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