BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4121873 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17801
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 4, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, LOT# VA0L5AM033, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, LOT# VA0HQHD012, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS CHARGING AND COULDN¿T GET MORE THAN TWO BARS SINCE IMPLANT. THE BATTERY WAS PALPATED AND THE MANUFACTURER¿S REPRESENTATIVE (REP) THOUGHT IT MIGHT HAVE BEEN FLIPPED. AN X-RAY WAS TAKEN WHICH SHOWED THE LEADS WERE COMING OFF TO THE LEFT AND THE DEVICE WAS CONFIRMED FLIPPED. IT WAS NOTED THAT SURGICAL ACTION WOULD BE TAKEN IN THE FUTURE TO CORRECT THE PROBLEM BUT THE PATIENT WANTED TO WAIT A FEW MONTHS AS SHE WAS STILL ABLE TO RECHARGE, AND ONLY NEEDED TO EVERY THREE WEEKS OR SO, BUT IT TOOK A LONG TIME; THERE WAS NO DATE SET AT THIS TIME. THE PATIENT WAS STILL RECEIVING EFFECTIVE THERAPY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600917 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1