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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 37612
Event Date 06/10/2015
Event Type  Malfunction  
Event Description

It was reported the patient programmer was not powering on and the recharger displayed a ¿call your doctor¿ icon and a 375 antenna failure error code. New batteries were tried in the programmer, but the issue was not resolved. The new batteries were brand new and the patient confirmed they were positioned correctly. The patient was not able to recharge the implantable neurostimulator (ins). When the patient tried to recharge the ins, they saw the ¿call your doctor¿ icon. Normally, the patient recharged just about every day. The patient was having a return of symptoms and their arm was shaking terribly since the day prior to this report. Upon device return, analysis of the patient programmer found the antenna jack was resoldered as a preventative measure. Upon device return, analysis of the recharger found the recharge antenna failed. 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.

 
Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v181305, implanted: (b)(6) 2009, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown, serial# unknown, product type: unknown. (b)(4).

 
Event Description

Additional information received reported that the patient received a replacement, therapy was working and the issue resolved with the replacement.

 
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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 Key4882203
Report Number3004209178-2015-12550
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2012
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/08/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/03/2011
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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