BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4203822 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20453
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2014: (B)(4) (REP): IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM ON THE DAY OF THE REPORT AND WAS COMPLAINING THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHOCKING HIM. THE PATIENT DID NOT HAVE THE PATIENT PROGRAMMER WITH HIM TO CHECK THE BATTERY AT THE TIME OF THE REPORT. THE PATIENT HAD A HISTORY OF DRUG USE AND IT WAS UNCLEAR WHETHER THE SHOCKING SENSATION WAS FROM THE THERAPY OR THE DRUG EFFECTS. IT WAS NOTED THAT THE PHYSICIAN TURNED OFF THE STIMULATION. THE PATIENT WAS DOING FINE. THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT NOT HAVING THE PATIENT PROGRAMMER WITH HIM ON A TRIP. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683495 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR