BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2862817 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11304
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    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 377645, LOT # V017401, PRODUCT TYPE LEAD; PRODUCT ID 377645, LOT # V013771, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3708160, SERIAL # (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 3708160, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAST IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT A PLUG GOT STUCK IN THE INS. THE DOCTOR DRILLED THE PLUG OUT. THERE WERE NO REPORTS OF LASTING THERAPY IMPACT DUE TO THE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT # 3004209178-2012-11303. THE PATIENT HAD TWO DEVICES AND IT WAS UNCLEAR WHICH DEVICE THE EVENT PERTAINED TO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1