RECLAIM DEEP BRAIN STIMULATION FOR OCD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-09 for RECLAIM DEEP BRAIN STIMULATION FOR OCD manufactured by .

Event Text Entries

[3396238] Following implantation, wife and son of subject (b)(6) reported seeing signs of cognitive impairment in the subject; specifically confusion, short term memory problems, difficulty structuring his thoughts and difficulty with word retrieval. Some examples were that the subject recently placed soap in the refrigerator and has confused the hot and cold knobs in the shower. Wife and son also reported that subject wandered across the street and appeared confused about how he got there. They note that these symptoms? Fluctuate depending on time of the day.? Subject appears to have some insight into the fact that he is experiencing cognitive changes. On (b)(6), when the patient came in for a modulation appointment, the principle investigator, dr (b)(6), requested an mri. Results the mri was read in the early evening and showed a small abscess and cerebritis along the left lead in the frontal lobe. These findings explained the observed changes in the pt? S mental status. The patient was admitted the evening of (b)(6), and surgery was completed in the afternoon on (b)(6) to explant the left electrode, extension leads and neurostimulator. Follow-up details. The abscess was drained and patient was placed on iv antibiotics. Culture showed growth of enterobacter. Patient had an uneventful post-operative course and was discharged on (b)(6) with a picc line in place for administration of antibiotics at home. Repeat mri showed resolution of abscess and reduction in left frontal lobe edema. On (b)(6), the patient saw dr (b)(6)(neurosurgeon) for removal of sutures and dr (b)(6) (psychiatrist) as an outpatient on (b)(6). Mental status examination of the patient showed a return to baseline. There was no evidence of confusion, memory disturbances or slowing of cognitive processing. The remaining right side ins was programmed and patient is scheduled to be seen again as an outpatient at the end of (b)(6). Route used: bilateral implantation. Diagnosis for use: obsessive compulsive disorder.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029675
MDR Report Key3050228
Date Received2013-04-09
Date of Report2010-07-21
Date of Event2010-07-08
Date Added to Maude2013-04-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameRECLAIM DEEP BRAIN STIMULATION FOR OCD
Generic NameNONE
Product CodeOLM
Date Received2013-04-09
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2013-04-09

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