BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3546780 · Received January 2, 2014

    Report

    Report Number
    3004209178-2014-00020
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# V909187, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-33, LOT# V941267, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿LAST (B)(6)¿ THE PATIENT HAD A TOTAL KNEE REPLACEMENT AND SINCE THEN HER BLADDER HAD BEEN MORE ACTIVE. THE PATIENT HAD NO WAY TO ADJUST HER STIMULATION BECAUSE SHE MISPLACED HER PROGRAMMER DURING HER MOVE "ABOUT THREE MONTHS AGO." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR