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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 Type  Injury  
Event Description

It was reported that the patient was experiencing paresthesia and difficulty walking. The symptoms had occurred following implant. The patient had had problems with her arms since the device was implanted in (b)(6) 2012. Both arms had problems, arms were swollen at night time and some nights it was more than others. The patient kept twisting and turning at night because of her arms. After discussing with her healthcare professional the patient was told she was fine. The healthcare professional was seen a long time ago and had not been seen since. The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing. The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change. The patient was unsure what was wrong with it because they were having problems with their head but now was having trouble with their neck. Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away. The patient had had it in both legs prior to surgery. After her legs were fine and her arms, but she could not sleep at night. The patient had a funny feeling in her arms. The healthcare professional told the patient that it had nothing to do with surgery. It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms. The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s. The patient had an appointment scheduled for (b)(6) 2014. The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about. The ct had been taken at the second surgery in (b)(6) 2012. The patient also had an appointment scheduled for (b)(6). 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. Reference manufacturer¿s report number: 3004209178-2015-00143.

 
Manufacturer Narrative

Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 3708660, 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 Key4384377
Report Number3004209178-2015-00144
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/16/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2015
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 Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/16/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/28/2012
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: 01/06/2015 Patient Sequence Number: 1
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