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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR

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MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR Back to Search Results
Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/26/2010
Event Type  Injury  
Event Description

Literature: ackermans l, duits a, temel y, et al. Long-term outcome of thalamic deep brain stimulation in two patients with tourette syndrome. J neurol neurosurg psychiatry. Oct 2010; 81 (10): 1068-1072. Summary: the authors conducted a follow-up study to report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described tourette patients. Reportable event: in patient 2, ((b)(6) male), the tic improvement at 8 months was slightly decreased at 6 years; compulsions had disappeared. This patient showed a decrease in verbal fluency and learning, a slight decrease in depression but overall psychopathology was still high at 6 years with an increase in anger and aggression together with difficulties in social adaptation. This patient reported a reduction in energy when the current intensity reached the level necessary for an optimal effect on tics; this patient did not adjust stimulation settings and preferred the feeling of drowsiness above his tics. This patient did experience a hardware-related complication consisting of traction of the lead in the neck. Multiple revisions of the wound and local injections were carried out with partial effect. This patient received seven replacements in 6 years due to his high-voltage stimulation. This patient experienced substantial improvement in sexual functioning at 8 months after surgery, but a slight decrease at the long-term follow-up except for sexual drive that increased to the maximum level. This patient experienced difficulty with his visual adaptation and vertigo, but neither of these complaints interfered with his daily life. Examination by an ophthalmologist did not reveal any disabilities. The adverse events experiences were not considered distressing at long term follow-up. See literature article with mfr report# 3007566237-2010-1064945.

 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

 
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Brand NameUNKNOWN DEEP BRAIN STIMULATOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave. n.e.
minneapolis MN 55421
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave. n.e.
minneapolis MN 55421
Manufacturer Contact
anne reali
7000 central avenue ne
rcw215
minneapolis , MN 55432-3568
7635269755
MDR Report Key1943662
Report Number3007566237-2010-10648
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 12/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPGNEURO
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/06/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/21/2010 Patient Sequence Number: 1
Treatment
LEAD: MODEL LEADMVD, LOT# UNKNOWN
EXPLANTED:
LEAD: MODEL LEADMVD, LOT# UNKNOWN
EXPLANTED:
IMPLANTED:
LOT# UNKNOWN
IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN
IMPLANTED:
EXPLANTED:
IMPLANTED:
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