BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1191117 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06154
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE RECHARGER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPLAINT WAS UNABLE TO BE VERIFIED. NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE PATIENT RECHARGER WAS RETURNED FOR ANALYSIS. COMPLAINT UNVERIFIED. BENCH TEST - DEVICE WAS USED TO RECHARGE TEST INS. RECEIVED ALL 8 BOXES. THE RECHARGE CIRCUIT AND TELEMETRY CIRCUIT WERE CHECKED FOR THE APPROPRIATE SIGNALS AT VARIOUS TEST POINTS. ALL THE CORRECT SIGNALS WERE THERE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A JOLT CAUSING THEM TO DOUBLE OVER WHILE GOING THROUGH THE THEFT DETECTOR AT THE GROCERY STORE IN 2008. THE PATIENT WAS NOT AROUND ANY KNOWN EMI SOURCES EXCEPT AT TIMES THEIR CELL PHONE IS IN THEIR POCKET NEAR THE INS BATTERY. THE PATIENT MAINTAINED GOOD STIMULATION AND WAS ABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER, BUT WAS UNABLE TO RECHARGE THE DEVICE SINCE THE EVENT. WHILE TRYING TO RECHARGE, THE PATIENT WAS HAVING DIFFICULTY ESTABLISHING COMMUNICATION. THE INS HAD VERY LITTLE CHARGE LEFT. THE ANTENNA DIAL WAS ADJUSTED MANY TIMES WITHOUT SUCCESS. THE PATIENT NORMALLY RECHARGES WHEN THE INS IS AT 50% CHARGE. THE CHARGE USUALLY TAKES 6 HOURS AND THE PATIENT HAS NOT HAD PREVIOUS DIFFICULTY RECHARGING. IT WAS ALSO REPORTED THERE WAS A 5-6 SECOND DELAY FOR THE PROGRAMMER TO COMMUNICATE. PREVIOUSLY, THERE WAS NO DELAY IN COMMUNICATION. THIS WAS FIRST NOTICED ABOUT TWO DAYS LATER. THE PATIENT WAS SEEN IN THE CLINIC WHERE A PHYSICIAN MODE RECHARGE WAS ATTEMPTED. AN ERROR CODE WAS RECEIVED INDICATING THE PROGRAMS HAD NOT BEEN SAVED. THE DEVICE HAD TO BE REPROGRAMMED. AFTER FURTHER TROUBLESHOOTING, COUPLING WAS ACHIEVED WITH THE PATIENT'S RECHARGER. THE PATIENT RETURNED HOME, BUT AGAIN EXPERIENCED DIFFICULTY GETTING BEYOND THE REPOSITION ANTENNA SCREEN. THE RECHARGER SHOWED THE "RECHARGE NOW" ICON THAT APPEARS WHEN THE BATTERY DROPS BELOW 2 VOLTS. A PHYSICIAN MODE RECHARGE WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 37082| PROGRAMMER: MODEL 37742| EXTERNAL DEVICE: MODEL 37751| LEAD: MODEL 3998| EXPLANTED| IMPLANTED