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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 Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389-40, lot# j0340291v, implanted: (b)(6) 2003, product type: lead; product id 748295, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389-40, lot# j0337392v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. (b)(4). F.

 
Event Description

It was reported that the patient was having spasms in her hands and arms on the night prior to the date of this report. The patient had used her medic alert necklace on the day prior to the date of this report. The necklace was taken off on the morning of the date of this report and the patient had not had spasms in her hands and arms. The patient was going to try and put the necklace back on to see what would happen. No outcome was provided regarding this 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: 3004209178-2014-18142.

 
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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 Key4134805
Report Number3004209178-2014-18143
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/14/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Date Manufacturer Received09/11/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/26/2013
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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