FDA Adverse Event Malfunction Summary report: N

SYNCHROMED EL

MDR report key: 1231225 · Received November 13, 2008

Report

Report Number
6000030-2008-07409
Event Type
Malfunction
Date Received
November 13, 2008
Date of Event
May 1, 2007
Report Date
October 13, 2008
Manufacturer
RICE CREEK MANUFACTURING
Product Code
LKK
PMA / PMN Number
P860004
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S KNEES "ARE GIVING OUT MORE FREQUENTLY WHILE WALKING." IT IS DIFFICULT FOR HIM TO GET BACK UP AND START MOVING AGAIN." IT WAS UNCLEAR WHEN THE EVENT BEGAN. THE PATIENT WAS BEGUN ON PHYSICAL AND WORK THERAPY IN 2007. THE PATIENT WAS IMPLANTED FOUR DAYS LATER, FOLLOWING AN EFFECTIVE SCREENING TRIAL. THE CATHETER WAS POSITIONED AT THE LEVEL OF T10. THE GABALON DOSE VIA THE PUMP WAS STARTED AT 50 MCG/DAY IN SIMPLE CONTINUOUS MODE. AT REFILL THE FOLLOWING MONTH, A 25% VOLUME DISCREPANCY WAS NOTED; EXPECTED RESERVOIR VOLUME WAS 14.8 ML AND ACTUAL WAS 14.0 ML. NO DEVICE TROUBLESHOOTING WAS REPORTED. AT REFILL TWO MONTHS LATER, THE DISCREPANCY WAS 12.5%. HIS FIRST NOTED DOSE ADJUSTMENT WAS ONE MONTH EARLIER, WHEN THE DOSE WAS DECREASED TO 45.0 MCG/DAY. THE DOSE WAS FURTHER DECREASED TO 40.0 MCG/DAY TWO WEEKS LATER, AND THEN INCREASED TO 43.2 MCG/DAY ONE WEEK LATER. KENNY SELF-CARE SCORES WERE NOTED TO BE IMPROVED WITH THE INTRATHECAL BACLOFEN THERAPY AND THERAPY WAS CONSIDERED EFFECTIVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

Patients

Seq Age Sex Outcome Treatment
1 49 YR Required Intervention ACINON| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| DANTRIUM| ARTANE| MEDICATIONS: CERCINE| CATHETER: MODEL 8711| TEMELIN| MUCOSTA| LENDORMIN| VOLATREN SUPPOSTITORIES| EXPLANTED:| CANTRIUM