BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2982333 · Received February 28, 2013

    Report

    Report Number
    6000032-2013-00048
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 389033, LOT # J0235487V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 389033, LOT # J0301151V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE LAST 2 MONTHS, THE PATIENT HAD OCCASIONAL STIMULATION. IT WAS STATED THAT "IT WAS SHOCKING , NOT PAINFUL AND NOT A SHOCK - BUT THE PATIENT WAS REFERRING TO SHOCK AS STIMULATION." THE PATIENT HAD IMPLANTABLE NEUROSTIMULATOR (INS) FOR PAIN IN HER RIGHT SHOULDER AND "FOR DOWN HER ARM." SHE HAD NOT TURNED OFF THE INS BUT IT TURNED ON AND OFF BY ITSELF "AS IF IT DECIDED WHEN IT SHOULD BE ON OR NOT." WHEN THE INS WAS NOT WORKING, SHE HAD VERY PAINFUL CRAMPS THAT STARTED IN HER SHOULDER AND CONTINUE DOWN HER ARM. IT WAS STATED IT HURT SO BADLY SHE WAS NOT ABLE TO LIFT HER ARM OR EVEN A LAUNDRY BASKET. IT WAS STATED THE INS HAD BEEN IMPLANTED IN 2003 "IN HER RIGHT UPPER CHEEK HIP AREA AND NOW HAD MIGRATED TO THE MIDDLE OF HER BUTT." THE PATIENT WAS NOT SURE IF THE INS REACHED END OF LIFE (EOL) OR IF THERE MIGHT BE "SOME SORT OF DISCONNECT BETWEEN THE WIRE AND THE INS." IT WAS STATED THE PATIENT HAD NOT HAD ANY FALLS NOR TRAUMA AT THE TIME OF THE LOSS OF STIMULATION. A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. MORE THAN TWO WEEKS LATER IT WAS REPORTED THAT IMPEDANCE OF 500 OHMS WAS READ ON MOST RESULTS AND ONE COMBINATION WAS READ AT 369 OHMS. IT WAS CONFIRMED THE PATIENT WAS FEELING STIMULATION AND GETTING THERAPY. INTERMITTENT STIMULATION WAS STATED. IT WAS STATED THAT THE PHYSICIAN FELT THE INS SHOULD BE REPLACED. CURRENT BATTERY MEASUREMENT OF 2.60 V WAS NOTED. IT WAS UNKNOWN IF THE ISSUE AFFECTED BOTH SIDES. THE PATIENT HAD THERAPY ON THE LEFT SIDE. THE TARGET SITE WAS "MORE ON THE LEFT SIDE AND SHOULDER" WHICH WAS UNCOMFORTABLE AND CRAMPING WHEN STIMULATION WAS OFF. A FRACTURE ON LEFT SIDE LEAD WAS SUSPECTED. THREE DAYS LATER IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. ALL IMPEDANCES WERE STATED AS NORMAL, ALL 500, SOME 369 OHMS. THE EVENT WAS POSSIBLY DUE TO THE BATTERY DEPLETION. THE ISSUE WAS DUE TO THE STIMULATION COMING ON SPORADICALLY. REPROGRAMMING HAD BEEN ATTEMPTED WITH NO CHANGES. REVISION WAS PENDING AND TO BE SCHEDULED IN THE NEAR FUTURE. X-RAY ASSESSMENT WAS PERFORMED WITH NORMAL RESULTS. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013. THE PROBLEM SEEMED MORE LIKELY RELATED TO A LEAD FRACTURE. SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT WERE INTERMITTENT STIMULATION. THERE WERE NO HOSPITALIZATION AND NO PATIENT INJURY. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT WOULD FEEL THE STIMULATION FOR A FEW MINUTES AND IT WOULD GO OFF FOR A FEW MINUTES. THE CYCLING SETTING WAS CHECKED AND IT WAS OFF. THIS WAS NOT RELATED TO POSITION CHANGES. THE STIMULATION WAS WITNESSED TURNING ON AND OFF WHILE THE PATIENT WAS STATIONARY. IT WAS SUGGESTED THAT THE PROBLEM MIGHT BE WITH THE LEAD OR THE EXTENSION. THE LEAD HAD BEEN IN FOR OVER 10 YEARS. A COMPLETE REVISION OF LEADS AND THE INS WAS PLANNED BUT THE DATE WAS NOT SCHEDULED YET. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86612 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1