BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2304212 · Received October 22, 2011

    Report

    Report Number
    3004209178-2011-08931
    Event Type
    Malfunction
    Date Received
    October 22, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3888-28, LOT # L75509, IMPLANTED: UNK, EXPLANTED: UNK; EXTENSION MODEL 7495-25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2000, EXPLANTED: UNK; ADAPTOR MODEL 74001, LOT # N243177, IMPLANTED: UNK, EXPLANTED: UNK; PROGRAMMER MODEL 37743, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT HAD USE OF HER STIMULATOR FOR THE PREVIOUS SIX MONTHS. THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS DEPLETED AND NEEDED TO BE REPLACED. THE PATIENT HAD BEEN TOLD THAT TESTING SHOWED THE DEPLETION MIGHT HAVE BEEN DUE TO FLUID IN THE CONNECTION. THE PATIENT WAS LOOKING INTO A REPLACEMENT, BUT HER INSURANCE WOULD ONLY COVER THE SURGERY AND WOULD NOT COVER THE COST OF A NEW DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. AN ADAPTOR WAS USED DURING THE PATIENT'S LAST DEVICE CHANGE OUT IN 2010, AND THE PATIENT HAD NOT EXPERIENCED THE SAME GOOD THERAPY FOLLOWING THE REPLACEMENT. REPROGRAMMING WAS ATTEMPTED AND DID NOT RESOLVE THE ISSUE. IMPEDANCE MEASUREMENTS WERE IN RANGE. THE PATIENT ALSO SAW AN ELECTIVE REPLACEMENT INDICATOR. THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION THERAPY, AND HAD NOT RECEIVED EFFECTIVE THERAPY FOR A NUMBER OF MONTHS. A SURGICAL INTERVENTION HAD BEEN DISCUSSED, BUT WAS NOT SCHEDULED. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS A LEAD FRACTURE, LEADING TO HIGH IMPEDANCES. THE STIMULATION WAS NOT WORKING. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THERE WAS NO PATIENT INJURY. THE HCP REPORTED THAT THE EXPLANT DATE WAS TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1