BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4112481 · Received September 24, 2014

    Report

    Report Number
    3004209178-2014-17606
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR COMPLAINED THAT THE SET SCREW ON 0-7 CHANNEL WAS TOO FAR IN AND THE LEAD WOULD NOT SEAT ALL THE WAY IN. THE DOCTOR DID NOT UNSCREW IT ALL THE WAY. THE 8-15 CHANNEL WAS THEN USED AND IT WORKED FINE. A PLUG WAS PUT IN 0-7 AND IT WORKED FINE. THE SET SCREWS ARE NOT CONSISTENT IN HOW FAR IN THEY ARE PLACED PRIOR TO IMPLANT. THE PATIENT WAS RECEIVING GREAT RESULTS WITH THE NEW BATTERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593365 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1