BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3785270 · Received May 1, 2014

    Report

    Report Number
    3004209178-2014-08396
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THE PUMP HAD BEEN BEEPING EVERY 10 MINUTES FOR THE PAST WEEK. THE PATIENT WENT TO HER DOCTOR ON (B)(6) 2014 WHICH WAS THE SCHEDULED REFILL DATE, BUT WHEN THEY CHECKED THE PUMP IT WAS EMPTY. THE PATIENT DID NOT KNOW HOW MUCH VOLUME WAS EXPECTED, BUT STATED THAT ¿THEY USUALLY GET SOME MEDICINE OUT¿. THE PATIENT DECLINED TO HAVE THE PUMP FILLED THAT DAY BECAUSE SHE WAS PLANNING TO HAVE THE PUMP REMOVED. THE PATIENT HAD AN APPOINTMENT (B)(6) 2014 WITH A SURGEON TO DISCUSS EXPLANT. BEFORE THE PUMP WAS IMPLANTED, THE PATIENT ¿WENT INTO SURGERY WITH NO ASSISTANCE, NO WALKER, NO CANE"; AFTER THE PUMP WAS IMPLANTED, THE PATIENT HAD TO STOP AND GET A CANE AND SHE HAD NEEDED ASSISTANCE WITH WALKING EVER SINCE. THE PATIENT ALSO HAD A "BITTER, NASTY TASTE¿ IN HER MOUTH LIKE CHARCOAL. THE PATIENT FELT THE PUMP WAS MALFUNCTIONING. IT WAS LATER REPORTED THAT BECAUSE THE PATIENT REFUSED TO HAVE THE PUMP REFILLED, THE CRITICAL ALARM WAS GOING OFF AND IT WAS BOTHERING THE PATIENT.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED HOSPITALIZATION FROM 2014-(B)(6) HAS BEEN CORRECTED TO 2013-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP FOR ABOUT A YEAR AND THE MEDICATION DOSE WAS STILL NOT RIGHT. THE PATIENT¿S HOME WAS STRUCK BY LIGHTNING ON (B)(6) 2013. THE PATIENT SAID IT WAS AS THOUGH HER FEET WERE LIKE ¿MAGNETS¿ TO THE CARPET. SHE ALSO DESCRIBED THAT ON (B)(6) 2013, IT FELT HER BED WAS ¿SUCKING¿ HER IN, SO MUCH THAT HER BODY LEFT AN IMPRINT ON THE MATTRESS. THERE WERE NO OTHER SYMPTOMS REPORTED. THE PATIENT DID NOT HEAR ANY ALARMS. THE PATIENT WAS GOING TO FOLLOW UP WITH HER HEALTH CARE PROVIDER. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION REVEALED THE PATIENT STILL HAD ISSUES, AS OF (B)(6) 2013, WITH HER BODY FEELING ¿MAGNETIC¿ SINCE HER HOME WAS HIT BY LIGHTNING. AT THE TIME HER HOME WAS STRUCK, SHE WAS NOT WEARING ANY SHOES. SHE HAD TO PLACE AN AIR MATTRESS ON HER BED, OR HOSPITAL BED, OTHERWISE HER BODY WAS ¿SUCKED TO IT¿ AND IT WAS ¿PAINFUL.¿ THE PATIENT WAS SEEN BY HER HEALTH CARE PROVIDER AND THE PUMP WAS ¿CHECKED¿ AND SAID TO BE ¿FINE.¿ ADDITIONAL INFORMATION REPORTED THE PATIENT¿S FEET WERE BURNING IN THEIR SHOES. IT WAS STATED THAT METAL STICKS TO THEIR BODY, ESPECIALLY THE SPRINGS IN THEIR BED AND IN CAR SEATS. IT WAS STATED THIS MADE THEM MISERABLE. IT WAS STATED THE PATIENT COULDN¿T ¿TAKE IT¿ AND WAS IN THE HOSPITAL FROM (B)(6) 2014. IT WAS NOTED THEY WERE STILL IN PHYSICAL THERAPY. IT WAS STATED THE PATIENT HAD NO ISSUE SINCE THE THEN. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT WITH THE SURGEON ON (B)(6) 2014. IT WAS STATED THE PATIENT HAD A ¿CHEMO¿ MEDICATION IN THE PUMP FOR MS AT ONE TIME

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP HAD BEEN DELIVERING LIORESAL (2000 MCG/ML AT 200 MCG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261296 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R