BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 996499 · Received February 6, 2008

    Report

    Report Number
    2182207-2008-00622
    Event Type
    Injury
    Date Received
    February 6, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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 PT 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 HIGH DOSE RADIATION DID NOT CAUSE ANY DAMAGE (BOTH CLINICAL AND PATHOLOGIC) TO THE PT AND THE ENVIRONMENT. REPORTABLE EVENT: MALE WITH SPASTICITY AND LOW BACK PAIN WAS IMPLANTED IN 2003. IN 2006, HE NOTICED A SIGNIFICANT INCREASE IN ABDOMEN SIZE, WORSENING LOW BACK PAIN, AND HAD BOUTS OF URINARY INCONTINENCE. A CT SCAN REVEALED THAT HE HAD A RETROPERITONEAL SARCOMA DIRECTLY UNDER HIS PUMP. THE PT WAS TREATED WITH CHEMOTHERAPY, RADIATION, AND SURGICAL RESECTION OF THE SARCOMA. AFTER CHEMOTHERAPY, IT WAS NOTED THAT THE SARCOMA SIZE HAD REDUCED AND SYMPTOMS OF BACK PAIN AND URINARY INCONTINENCE IMPROVED. AS OF 2007, THERE HAD BEEN NO RECURRENCE OF THE SARCOMA.

    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 Hospitalization| R PROGRAMMER MODEL UNK| IMPLANTABLE CATHETER MODEL UNK