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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
Event Type  Injury  
Event Description

Additional information received reported that there was a 50% or greater symptom reduction. The cause of the event was not determined, but it was not device related and did not require reprogramming. The patient was hospitalized due to disorientation and confusion. The patient was in a group home setting as well. No interventions or action were taken and the patient outcome was unknown.

 
Manufacturer Narrative

Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389s-40, lot# v333543, implanted: (b)(6) 2009, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389-40, lot# l75963, implanted: (b)(6) 2000, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 7495-25, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. (b)(4).

 
Event Description

An emergency room (er) doctor reported that the patient had a sudden loss of therapeutic effect as it happened within the past one or two days. The patient presented to the er on the day of the report with decreased alertness and tonic-clonic tremors in his arms and legs. The symptoms were worse on the left side than the right. The patient¿s wife felt like this was a return to baseline symptoms for him. It was requested that a manufacturer representative come check the patient¿s system as there was no patient programmer available. No patient intervention or outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

 
Manufacturer Narrative

(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 Key3999664
Report Number3004209178-2014-15118
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/28/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/04/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/04/2013
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: 08/11/2014 Patient Sequence Number: 1
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