BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2874146 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11855
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 27, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3587A25, LOT# N133918, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED AT HIS FOLLOW-UP APPOINTMENT, WAS DOING WELL, AND FELT ST IMULATION WHERE NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS HAD TO RUN STIMULATION AT HIGHER RATE THAN NORMAL. IT WAS STATED THAT THE PATIENT USUALLY HAS THE DEVICE SET TO 1.5V SINCE IMPLANTATION 1 YEAR AGO. IN THE PAST 4-5 MONTHS THE PATIENT HAD TO TURN STIMULATION UP TO 9 V TO GET BENEFIT. IT WAS NOTED THAT A REVISION WAS GOING TO BE DONE TO SEE WHY THE PATIENT NEEDED TO TURN UP THE DEVICE SO HIGH TO GET BENEFIT. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2012. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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 Required Intervention