BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4482076 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01699
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Report Date
    January 13, 2015
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N230604, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD GASTRIC SLEEVE SURGERY ON (B)(6) 2014 AND SINCE THEN HAD LOST 62 POUNDS. ON (B)(6) 2015, THE PTM (PERSONAL THERAPY MANAGER) WOULD NOT COMMUNICATE WITH THE PUMP. THIS HAD HAPPENED SINCE THE PATIENT HAD DRIVEN FOR 8 HOURS TO PICK UP HIS SON FROM SCHOOL. THE PATIENT WAS WONDERING IF THE CHANGE IN HIS WEIGHT COULD HAVE AFFECTED THE COMMUNICATION BETWEEN THE PTM AND THE PUMP. PER THE PATIENT, THE PUMP ¿SEEMS MORE POOFED OUT¿ AND ¿FEELS DIFFERENT¿. THE PATIENT WAS CONCERNED THAT THE PUMP HAD FLIPPED. THE NIGHT PRIOR TO THIS REPORT, THE PATIENT SUDDENLY BECAME PANICKY, IT FELT LIKE HIS SKIN WAS CRAWLING, HE HAD HEAVY BREATHING, AND HIS HEART WAS POUNDING. HE TOOK A ¿NERVOUS PILL¿ FOR IT; BUT IT ONLY HELPED FOR A WHILE. AT THE LAST PUMP REFILL ON (B)(6) 2015, THE PATIENT WAS TOLD THAT HIS PUMP WOULD NEED TO BE REPLACED IN 19 MONTHS. THE DEVICE SYSTEM WAS DELIVERING HYDROMORPHONE. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81269 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR