BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1324322 · Received February 23, 2009

    Report

    Report Number
    2182207-2009-01231
    Event Type
    Injury
    Date Received
    February 23, 2009
    Date of Event
    September 1, 2008
    Report Date
    January 26, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROTATED PUMP.

    Description of Event or Problem · 1

    LITERATURE: MARQUARDT G, BECK J, SEIFERT V. [AN UNUSUAL COMPLICATION IMPEDING REFILLING OF A PUMP USED FOR INTRATHECAL BACLOFEN THERAPY]. REV NEUROL. 2008; 27(10):557-558. A FEMALE WITH SPASTIC TETRAPARESIS WAS TREATED WITH ORAL ANTISPASTIC DRUGS AND PERIODIC BOTULIN TOXIN WITHOUT DESIRED THERAPEUTIC EFFECT. AN INTRATHECAL BACLOFEN PUMP SYSTEM WAS IMPLANTED WITH NO COMPLICATIONS; IT PROVIDED NOTABLE IMPROVEMENT IN SPASTICITY AND QUALITY OF LIFE. THE PUMP WAS REFILLED SEVERAL TIMES WITHOUT DIFFICULTY. SUBSEQUENT TO THE PATIENT'S MARKED WEIGHT GAIN, THE PUMP COULD NOT BE REFILLED. THE SEPTUM COULD NOT BE PUNCTURED. A RADIOLOGIC STUDY REVEALED THE PUMP HAD ROTATED ON ITS AXIS: THE OUTER SURFACE WAS FACING TOWARD THE ABDOMINAL CAVITY AND THE BASE WAS TURNED UPWARD. DAYS EARLIER, THE PATIENT NOTICED A SLIGHTLY PAINFUL BULGING AT THE PUMP SITE WHICH LASTED A SHORT TIME AND DISAPPEARED SPONTANEOUSLY. SURGICAL EXPLORATION WAS REFUSED. THE PUMP WAS GRASPED MANUALLY, LIFTED THROUGH THE SKIN AND ROTATED BACK. X RAY CONFIRMED CORRECT POSITION OF THE PUMP AFTER THIS WAS DONE AND REFILLING WAS EASY. SPASTICITY INCREASED ENORMOUSLY AFTER THIS AND THE PATIENT EXHIBITED RESISTANCE TO REPEATED INCREASES IN THE DOSE OF BACLOFEN. A RADIOLOGIC STUDY SHOWED THE CATHETER TIP HAD SLIPPED OUT OF THE INTRATHECAL SPACE. DURING THE EXPLORATORY SURGERY, A NEW CATHETER WAS CONNECTED TO THE PUMP. THE PUMP WAS NOT ATTACHED TO THE SUBCUTANEOUS POUCH; THE PUMP WAS REATTACHED TO THE FASCIA. THERE HAVE NOT BEEN ANY FURTHER INCIDENTS IN THE CLINICAL EVOLUTION OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL| PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED: