BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3811423 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08949
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LEAD WAS REPLACED DUE TO HAVING ¿SHORTED OUT.¿ IT WAS STATED THE PATIENT¿S PHYSICIAN ¿DID SUCH A GOOD JOB AT REPLACING THE LEAD THAT THE PATIENT WAS ABLE TO USE THE SAME PROGRAM THAT HE HAD BEFORE THE REPLACEMENT.¿ THE PATIENT NOTED THEIR STIMULATOR WORKED GREAT FOR THEIR PAIN. ADDITIONAL INFORMATION STATED THE PATIENT¿S LEAD SHORTED OUT AND WENT ¿HAYWIRE.¿ IT WAS FURTHER STATED THAT ELECTRODE 4 HAD SHORTED. THE PATIENT REPORTED THE LEAD SHORTED OUT NINE MONTHS AFTER IMPLANT. THE PATIENT NOTED IT WAS HIS FAULT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290025 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention