FDA Adverse Event Injury Summary report: N

RECLAIM DEEP BRAIN STIMULATION FOR OCD

MDR report key: 3050228 · Received April 9, 2013

Report

Report Number
MW5029675
Event Type
Injury
Date Received
April 9, 2013
Date of Event
July 8, 2010
Report Date
July 21, 2010
Product Code
OLM
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
144306 RECLAIM DEEP BRAIN STIMULATION FOR OCD NONE OLM

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization| R ZIAC| CREON| PROZAC| AMBIEN