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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Injury  
Event Description

It was reported that the last few weeks had been terrible for the patient. She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured. Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down. Her leg strength was completely gone and simply would not support her body. The patient also had significant pain in her neck that never seemed to diminish. Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time. She could barely perform the basic functions to care for herself. Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger. The patient had minimal trouble walking before implant, but could hardly walk at the time of the report. She was at the two month mark post-surgery and had seen little improvement in her condition. Her overall condition was significantly worse at the time of the report than prior to implant. The only caution presented prior to surgery was that her iq might drop a few points. The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old. ¿ the reporter questioned her overall competency. Adjustments to the device had yielded little improvement. The patient could not go on like this much longer as her health was deteriorating rapidly. Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction. The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015. It was unknown how the patient was doing, but the therapy was being delivered. The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date. If additional information is received a supplemental report will be sent.

 
Manufacturer Narrative

Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642,serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. (b)(4).

 
Event Description

Additional information received reported the patient had made little progress since their last report. The patient had an appointment scheduled with their healthcare professional (hcp) on (b)(6) 2015. The reporter hoped a ct scan would shed some light on why the patient continued to have problems. A ct scan found that in the interval there were findings of deep brain stimulation postoperative changes with bilateral frontal burr holes. The leads were in good anatomic position. There were right frontal subcutaneous postoperative changes with the leads. There appeared to be patch ill define contrast enhancements involving the right posterior frontal cortex and subcortical white matter adjacent to the metallic artifact form the leads. The possibility of an infections or neoplastic process could not be excluded with the examination. The patient's third and fourth lateral ventricles remain mildly increased in size with a proportionate increase in size of the cortical sulci and subarachnoid spaces of the posterior fossa indicative of diffuse mild cerebral and cerebellar atrophy. The multiple areas of mildly decreased density involving the periventricular and subcortical white matter was consistent with white mater changes of aging and microvascular disease.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key4841044
Report Number3004209178-2015-11545
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/16/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/27/2015
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: 06/12/2015 Patient Sequence Number: 1
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