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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  
Manufacturer Narrative

 
Event Description

It was reported that the patient had thought the deep brain stimulator would have a positive effect on the quality of life but it had been the opposite. The patient had first had surgery to help the right side tremor and it had gone well so they decided to have the left side done which was in (b)(6) 2013. That was when the problems had started and they had not stopped. Side effects impacted the patient¿s balance and speech which eventually lead to the patient falling. Following a series of tests they found out the patient had a brain infection. The patient spent time in the hospital getting treated for the infection and was still trying to get ¿c. Diff¿ under control. It was noted that it had been one thing after another and the patient had believed it all started with the frayed wire. The patient was still doing out patient rehab to help with balance and speech but the patient had been told speech would not get much better. The patient was concerned not much would get better. It had been a disaster. There were serious side effects that would impact the patient¿s family and him the rest of his life. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0bh3r, implanted: (b)(6) 2014, product type: lead, product id: 3387s-40, lot# va0b0xv, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Event Description

Additional information received reported the patient started having trouble with balance and speech after a revision surgery. Due to balance issues, the patient fell and ended up in the hospital. While the patient was in the hospital, an mri was done and they found a brain infection. The lead had to be explanted and the patient spent several weeks in intense rehab learning how to walk and talk again.

 
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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 Key4460634
Report Number3004209178-2015-01350
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/14/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/07/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/17/2013
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: 01/28/2015 Patient Sequence Number: 1
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