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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Low Battery
Event Type  Injury  
Event Description

It was reported that the deep brain stimulation (dbs) did not help the reporter's husband. It was a huge disappointment when the battery unit was turned on and nothing happened. It was a horrible month of healing from both surgeries and then nothing. The patient was still taking all medications and the tremors were horrible. The therapy had been a nightmare for the patient and his wife. The patient got delirium, as it was an extreme case. There was extreme pain during the surgery and also sleep deprivation. The first week after surgery, the patient's wife thought she was going to have to put him in a straight jacket. They were shown the miracle of what happens when the battery was turned on for other patients, however, this did not happen with the patient. The delirium went on for a solid week and the patient was never able to reduce their medication. On the day of the surgery the patient was taking 250 cd/ld every 2 hours and he was still taking that after the battery was turned on. The patient did walk better. His face still looked frozen but it was a little better. The patient was slow thinking, had no conversations anymore, and was a little pissy. The patient was always a super nice, kind guy but not after the surgery. The patient's wife was told, "it's brain surgery, he's gotta heal, etc. " but they did not tell her all the stuff that would happen. When asked a question, the patient would stare into space and not answer. The patient's wife was told that all the symptoms would be gone after six months and the programming would need to be fine tuned several times. She was also told that they never said the medication would be reduced and to give it a chance. The husband and wife left the neurologist's office two days prior to the report and going to the office did not work, which was shocking to them. They were telling people who called that it did not work. There was no change and it was very disappointing. No outcome or intervention was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

 
Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, product type: lead. (b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information received from the consumer reported that the patient was not a success and would have to have it redone in a few years.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information received from the consumer reported that the month after the patient was implanted on (b)(6) 2015 was ¿pure hell,¿ and that when the battery was turned on it did not work, and still wasn¿t working. At the beginning, the consumer stated they thought the patient would ¿never be normal mentally again. ¿ the reporter considered the deep brain stimulator (dbs) therapy to be a ¿total failure so far;¿ there had been ¿no relief at all¿ for the patient. It was noted that the only improvement was that the patient¿s medications lasted three hours versus two hours, but there was no reduction in medication. It was stated that the dbs was implanted to improve motor function/tremors but ¿none of that [has] happened so far. ¿ it was added that the patient¿s speech had become affected. The consumer reported that ¿every day something else happens that worries us!¿ on an unknown date the patient¿s neurologist recommended that in 3-4 months if the programming still had not had any results they would recommend that they get a scan to see if the electrodes were placed incorrectly. The consumer stated it appeared as though the electrodes were in the wrong place, but the patient felt that they would not want to go through the surgery again. A week later, consumer added that they thought the implanting surgeon implanted the electrodes in the wrong locations. No outcome or intervention was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
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 Key4929592
Report Number3007566237-2015-02040
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2015
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/21/2015 Patient Sequence Number: 1
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