FDA Adverse Event Injury Summary report: N

DEEP BRAIN STIMULATION LEAD (X2)

MDR report key: 1002342 · Received February 22, 2008

Report

Report Number
2182207-2008-00888
Event Type
Injury
Date Received
February 22, 2008
Date of Event
November 2, 2007
Report Date
January 23, 2008
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
MHY
PMA / PMN Number
P960009
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PT UNDERWENT DEEP BRAIN STIMULATION IMPLANT; DURING STAGE ONE SURGERY IN 2006, HE SUFFERED ACUTE ISCHEMIA IN THE RIGHT FRONTAL LOBE, WHICH WAS DIAGNOSED AS CVA SECONDARY TO DBS IMPLANT. HE HAD REHABILITATION; THE PT RECEIVED PHYSICAL AND OCCUPATIONAL THERAPY AND RETURNED TO BASELINE EXCEPT FOR SLIGHT WEAKNESS IN HIS LOWER EXTREMITY, WHICH HAD BEEN ATTRIBUTED TO CVA. AT FOLLOW-UP WITH THE HCP VIA PHONE ON 1/9/2008, THE PT'S DAUGHTER REPORTED THAT THE PT HAD FALLEN IN 2007, AND SUBSEQUENTLY EXPERIENCED LEFT HIP PAIN WITH AN INABILITY TO STAND OR WALK. EXAM AT THE EMERGENCY ROOM HAD REVEALED A FRACTURED LEFT-HIP FIVE DAYS PRIOR. THE PT WAS ADMITTED TO THE HOSPITAL TWO DAYS LATER FOR LEFT-HIP HEMIARTHROPLASTY AND EXPERIENCED PROLONGED HOSPITALIZATION SECONDARY TO LEFT-SIDED WEAKNESS. POST-OPERATIVELY THE PT WAS CONFUSED; THE CONFUSION HAD BEEN ATTRIBUTED TO TREATMENT WITH MORPHINE, WHICH WAS DISCONTINUED. THE PT HAD BEEN TRANSFUSED WITH TWO UNITS OF BLOOD FOR A REPORTED DROP IN HEMOGLOBIN (PERTINENT TEST RESULTS WERE NOT AVAILABLE). THE FOLLOWING DAY, THE PT HAD BEEN DISCHARGED TO A REHABILITATION CENTER AND THEN TO A NURSING HOME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEEP BRAIN STIMULATION LEAD (X2) MHY MEDTRONIC NEUROMODULATION UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 73 YR Hospitalization| R ZOFRAN| LORTAB| TRADOL| PROTONIX| EXPLANTED| IMPLANTED| EXTENTSION MODEL UNK LOT#UNK| IMPLANTED| LOT #UNK| IMPLANTABLE NEURO STIMULATOR MODEL 7428| MEDICATIONS: SINEMET 25/100| ARIXTRA| EXPLANTED| EXTENSION MODEL UNK LOT# UNK| TYLENOL| IMPLANTED| EXPLANTED