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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

It was reported that stimulation was turning off on its own and the patient did not know what was causing it. The patient was not feeling confident with the patient programmer and inquired if he was reading the programmer right. The patient had had programming done in (b)(6) 2015 and programming was not helping with symptoms. The patient had called their healthcare professional about this. On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and he was seeing stimulation at 2. 5v on one side and 3. 5v on the other side and it said off on the top. The ins was turned back on. The ins had turned off on saturday prior to the date of this report and it was a normal day. It was off on monday and the left arm was paralyzed, he could not lift his arm or move his elbow over his shoulder. The patient takes 9 doses of sinemet and had stated he had ¿worst days and bad days and the bad days are not good. ¿ the patient was in a wheel chair. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (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 Key4865984
Report Number3004209178-2015-12134
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 06/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2013
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/03/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/02/2012
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: 06/24/2015 Patient Sequence Number: 1
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