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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MDT PUERTO RICO OPERATIONS CO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problem Electromagnetic Interference
Event Type  Malfunction  
Event Description

Additional information indicated that the patient's family had a hard time determining if the meter was effecting the patient or if they symptoms were just a progression of the patient's parkinson's disease. The health care provider stated that this was the first time they had come across a smart meter potentially affecting a neurostimulator. They also were unsure if the smart meter is effecting the patient's neurostimulator or not. The patient was trying to have the electric meter replaced with the old mechanical one. If additional information becomes available, a follow-up report will be sent.

 
Manufacturer Narrative

 
Manufacturer Narrative

Lead model 3389s-40, lot#v530287, implanted: 2010-(b)(6), explanted: unk, extension model 37085-60, serial #(b)(4), implanted: 2010-(b)(6), explanted: unk, extension model 37085-60, serial #(b)(4), implanted: 2010-(b)(6), explanted: unk.

 
Event Description

It was reported that the patient had been feeling dizzy and was losing balance when walking after an electric meter was installed the previous day. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55431
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431
7635263987
MDR Report Key2353116
Report Number3004209178-2011-09499
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/14/2011
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/20/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/15/2010
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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