FDA Adverse Event Injury Summary report: N

SYNCHROMED

MDR report key: 914664 · Received September 14, 2007

Report

Report Number
2182207-2007-02940
Event Type
Injury
Date Received
September 14, 2007
Report Date
August 20, 2007
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
LKK
PMA / PMN Number
P860004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

CRUIKSHANK, ET AL. "INTRAVENOUS DIAZEPAM INFUSION IN THE MANAGEMENT OF PLANNED INTRATHECAL BACLOFEN WITHDRAWAL." DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY. 2007; 49: 626-628. PT'S PUMP HAD TO BE REPOSITIONED AFTER X-RAY SHOWED ROTATION. THE ARTICLE DESCRIBES A MALE WITH CEREBRAL PALSY WITH QUADRIPLEGIA HAD A BACLOFEN PUMP IMPLANTED 5 YEARS PREVIOUSLY. A YEAR PREVIOUSLY, HIS PUMP REQUIRED REPOSITIONING AS X-RAYS CONFIRMED THAT IT HAD ROTATED. SIX MONTHS LATER, THE PUMP HAD SLIPPED AGAIN AND AN AREA OF PRESSURE NECROSIS AND CELLULITIS HAD DEVELOPED. IN VIEW OF THE FACT THAT HE WAS DUE FOR A NEW PUMP INSERTION THAT YEAR, AS HIS PUMP BATTERIES WERE DUE TO RUN OUT, IT WAS DECIDED TO REMOVE ELECTIVELY HIS PUMP TO ALLOW THE INFECTION TO RESOLVE. POST OP HE WAS COMMENCED ON A DIAZEPAM INFUSION WHICH WAS DISCONTINUED AFTER 42 HOURS, HE WAS THEN COMMENCED ON ORAL BACLOFEN. THE PROCEDURE AND POST OP COURSE WERE UNEVENTFUL. HE DID NOT DEVELOP WORSENING SPASTICITY OR DYSTONIC SPASMS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

Patients

Seq Age Sex Outcome Treatment
1 16 YR Hospitalization| R IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| EXPLANTED:| CATHETER MODEL CATHETER LOT# UNK