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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 37603
Event Date 08/15/2014
Event Type  Malfunction  
Event Description

It was reported they were unable to adjust stimulation. They questioned whether the stimulation was on or not. The device was powered off. Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off. The patient¿s stimulation was turned back on for therapeutic use. The symptoms had a sudden onset. The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer. The patient had noticed a difference in stimulation on the morning of report. The patient had freezing of their left leg and foot. They had been having problems with the therapy for the last week. They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment. The last programming adjustment helped with their prior symptoms ¿for the most part. ¿ the patient felt okay. The stimulation was noted to be back on.

 
Manufacturer Narrative

Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead. (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 Key4073049
Report Number3004209178-2014-16626
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/15/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/14/2013
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/15/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/14/2011
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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