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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 37602
Event Type  Malfunction  
Event Description

It was reported that there was a loss of therapeutic effect, the patient¿s hand had been shaking badly and ¿like crazy¿ for about 3 weeks prior to the date of this report. The patient thought something electrical had turned her implant off and did not have the programmer to check. The patient¿s status was unknown. The patient¿s programmer had been lost or stolen and she could not wait to get a new one. No patient outcome was provided regarding the event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2014-20904.

 
Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0jy0m, implanted: (b)(6) 2014, product type: lead. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0g100, implanted: (b)(6) 2014, product type: lead. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

 
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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 Key4224171
Report Number3004209178-2014-20906
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/28/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/14/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/08/2014
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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