BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3011604 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03946
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT'S BATTERY WAS DEPLETED AND IT WAS REPLACED. IT WAS ALSO REPORTED, THE HEALTHCARE PROVIDER BELIEVED THE BATTERY HAD NORMAL DEPLETION. DURING THE BATTERY REPLACEMENT FLUOROSCOPY WAS USED AND IT WAS NOTED ONE OF THE LEADS, WHICH WAS NOT USED IN THE PATIENT'S PROGRAMMING, HAD MIGRATED DOWN INTO THE BATTERY POCKET. IT WAS REPORTED THE PATIENT HAD BEEN RECEIVING ADEQUATE THERAPY PRIOR TO THE REPLACEMENT SO THE LEAD WAS REMOVED AND NOT REPLACED. FOLLOWING THE REPLACEMENT, IT WAS REPORTED THE PATIENT WAS "DOING WELL" AND RECEIVING ADEQUATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114074 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1