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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 the patient¿s behavioral changes, speaking and choking had nothing to do with their deep brain stimulator. It was noted that it was being handled in a different manner.

 
Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

 
Event Description

It was reported that in order to control the patient¿s parkinson¿s disease tremors stimulation had to be turned up high but that resulted in the patient barely being able to speak. The patient slurred like he was drunk and had choking issues. The patient was never able to go off medication as he had been promise prior to surgery. The patient had changes in behavior after surgery also. The healthcare professional had been treating the patient for depression as well. It was noted that the patient had lost his job after surgery and the patient¿s father had bipolar issues. The deep brain surgery had been in 2010. The patient¿s wife was concerned about the patient¿s safety. The patient had depression since the original implant, he was on 2 depression medications which had made him suicidal. The depression continually gets worse each time they had increased the 2 oral medications. The patient had also developed behavioral changes which included obsessive compulsive disorder, hermit, reclusive, paranoia, delusions, insensitive, no filter when he speaks to people, domineering, rage issues especially when driving, and violence. The patient has also broken things and broken his own ribs in one of his rage fits while breaking things. The patient was aggressive with his children. The patient had moved out of the house and would not speak to his wife. The patient had always been loving, kind and respectful but all that had gradually begun to change since the deep brain stimulator was originally implanted but specifically when oral depression medication was introduced. Reference manufacturer¿s report number: 3004209178-2015-08285 for patient¿s current system.

 
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 Key4742823
Report Number3004209178-2015-08291
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/28/2011
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/11/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/13/2010
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: 05/01/2015 Patient Sequence Number: 1
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