BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3925603 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12780
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 9 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE OR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2014 AND NO LONGER HAS CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS TO ¿TAKE IT OFF¿ WHEN THEY ARE DRIVING AND NOT GETTING RELIEF ON THE LEFT SIDE SINCE IMPLANT AND THEN WHEN THEY CHARGE FOR OVER AN HOUR OR SO AND GETS A FULL BATTERY IT WILL ONLY LAST 3 HOURS BEFORE IT NEEDS TO BE RECHARGED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404145 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR