BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4781588 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-09368
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 12, 2015
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97791, LOT# N368014, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS CHARGED AND IT WAS NOT WORKING RIGHT FOR THE PAST 4 DAYS. WHEN THE PATIENT GOT HOME, THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED ITSELF OFF. WHEN SHE CHECKED THE INS, IT WAS HALF CHARGED. THE VIBRATION SEEMED TO BE VERY WEAK. IT WAS NOT WORKING CORRECTLY. SHE NEEDED HER IMPLANT TO WORK BECAUSE IT DID HELP. IT WAS LATER REPORTED THAT THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. IT WAS UNKNOWN WHICH COMPONENTS WERE INVOLVED BUT NO TROUBLESHOOTING WAS DONE. THE CAUSE OF THE EVENT WAS NOT DETERMINED BUT IT WAS NOT DEVICE RELATED. PATIENT EDUCATION WAS TAKEN TO RESOLVE THE ISSUE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326043 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR