BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 996500 · Received February 6, 2008

    Report

    Report Number
    2182207-2008-00635
    Event Type
    Injury
    Date Received
    February 6, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE INDICATES THAT THE DEVICE WAS RETURNED FOR ANALYSIS, HOWEVER WITHOUT DEVICE ID, WE CAN NOT CONFIRM.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: WU ET AL. "RADIATION-INDUCED ALARM AND FAILURE OF AN IMPLANTED PROGRAMMABLE INTRATHECAL PUMP." CLIN J PAIN 2007; 23(9): 826-828. THIS ARTICLE DESCRIBES A CASE STUDY OF ONE PATIENT WITH SPASTICITY WHO REPORTED AN ALARM AND FAILURE OF AN IMPLANTED PROGRAMMABLE, IT PUMP IN A TURN-OFF STATUS EXPOSED DIRECTLY TO RADIATION USED FOR TREATMENT OF A RETROPERITONEAL SARCOMA. AN ESTIMATED CUMULATIVE DOSE EXPOSED TO THE ELECTRONIC CIRCUIT AND/OR BATTERY TO CAUSE THE ALARM AND DEVICE FAILURE WAS IN THE RANGE OF 28.5 TO 36 GY IN 20 DAILY TREATMENTS. HOWEVER, THE PUMP DIRECTLY EXPOSED TO HIGHDOSE RADIATION DID NOT CAUSE ANY DAMAGE (BOTH CLINICAL AND PATHOLOGIC) TO THE PATIENT AND THE ENVIRONMENT. REPORTABLE EVENT: A MALE WITH SPASTICITY AND LOW BACK PAIN WAS IMPLANTED IN 2003. AFTER BEING DIAGNOSED WITH A RETROPERITONEAL SARCOMA AND BEING TREATED WITH CHEMOTHERAPY, THE PATIENT'S PUMP WAS TURNED OFF FOR RADIATION TREATMENT DUE TO CLOSE PROXIMITY OF THE PUMP TO THE SARCOMA. THE MORPHINE AND BACLOFEN WERE REPLACED WITH NORMAL SALINE DURING THE RADIATION TREATMENT. AFTER COMPLETING 20 RADIATION TREATMENTS, THE IT PUMP STARTED TO ALARM WITH CONSTANT SOFT BEEPING. INTERROGATION WAS ATTEMPTED, BUT THE READING "INVALID TELEMETRY, ERROR" WAS SHOWN ON THE COMPUTER SCREEN ON THE PUMP. THE ALARM LASTED FOR FOUR DAYS AFTER WHICH IT SPONTANEOUSLY STOPPED WITHOUT INTERVENTION. AFTER THE PUMP'S ALARM WENT OFF AND A FAILED INTERROGATION, A MALFUNCTION WAS SUSPECTED. UPON RETURN TO MEDTRONIC, A PUMP ANALYSIS REVEALED THAT THE BATTERY WAS COMPLETELY DEPLETED, WHICH WAS MOST LIKELY CAUSED BY THE HIGH CURRENT DRAIN ASSOCIATED WITH RADIATION SECONDARY TO ELECTRONIC CIRCUIT DAMAGE AND/OR DIRECT EFFECT TO THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTABLE CATHETER MODEL UNK| PROGRAMMER MODEL UNK