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

Model Number NEU_INS_STIMULATOR

Device Problem Low Battery (2584)

Patient Problems Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Irritability (2421); Shaking/Tremors (2515); Sleep Dysfunction (2517); Cognitive Changes (2551)

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).

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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, 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 Key: 4929592
• MDR Text Key: 6430648
• Report Number: 3007566237-2015-02040
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other