BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2843752 · Received November 23, 2012

    Report

    Report Number
    6000032-2012-00203
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# J0421683V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "NOT GETTING ADEQUATE STIMULATION IN ONE AREA." IT WAS NOTED THAT THE PATIENT WENT IN FOR PROGRAMMING AND WANTED TO PROGRAM CYCLING IN ORDER TO INCREASE BATTERY LIFE. IT WAS STATED THAT DUE TO INADEQUATE STIMULATION, THE PATIENT MAY HAVE TO INCREASE SETTING OVER TIME. IT WAS NOTED THAT THE PATIENT USED THERAPY "OFF AND ON," AND IT HAD "BEEN AWHILE" SINCE THEY USED IT LAST. IT WAS LATER REPORTED THAT THE BATTERY WAS NEARING END OF LIFE (EOL). IT WAS STATED THAT THERE WERE NO MALFUNCTIONS, IMPEDANCE CHECK SHOWED READINGS WITHIN "NORMAL" LIMITS, AND THE PATIENT WOULD DISCUSS BATTERY CHANGE WITH PHYSICIAN. IT WAS NOTED THAT THE PATIENT WAS RECEIVING "ADEQUATE STIMULATION" AFTER REPROGRAMMING BUT THE PATIENT WILL EXPERIENCE "INCREASING AMPLITUDE" AND THE BATTERY "EVENTUALLY WILL DEPLETE." FOUR DAYS LATER, IT WAS REPORTED THAT IMPEDANCES REFLECTED THAT "2ND SIDE" DID NOT HAVE THE LEAD INTACT. IT WAS STATED THAT "MULTIPLE" REPROGRAMMINGS WERE ATTEMPTED "WITHOUT SUCCESS." IT WAS NOTED THAT THERE WERE STILL NO MALFUNCTIONS. NO INTERVENTIONS WERE TAKEN OR PLANNED "YET," AND THE PATIENT WAS STILL GETTING ADEQUATE THERAPY THOUGH THE BATTERY WAS "LOW." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1