BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6073035 · Received November 2, 2016

    Report

    Report Number
    3004209178-2016-23065
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 11, 2016
    Report Date
    November 21, 2016
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR NON-MALIGNANT PAIN AND PERIPHERAL NEUROPATHY REPORTED AFTER CHANGING OUT THE AAA BATTERIES IN THEIR PROGRAMMER ON (B)(6) 2016 THEY WERE INTERMITTENTLY FEELING "BOLTS OF ELECTRICITY" THROUGH THEIR BODY. IT WAS NOTED THE SHOCKING SENSATION WAS NOTICED WHILE SITTING, RAISING THE LEFT ARM, OR LAYING DOWN. THE CONSUMER TURNED STIMULATION DOWN, BUT WAS STILL EXPERIENCING A SLIGHT SHOCKING SENSATION. ON (B)(6) 2016 THE CONSUMER CALLED BACK AND STATED THE ISSUES HAD BEEN TAKEN CARE OF AND WAS RESOLVED, AND THE ISSUES WERE DUE TO A CHANGE IN BATTERIES. HOWEVER, NOW THE CONSUMER WANTED THE MANUFACTURER'S REPRESENTATIVE (REP) TO REPROGRAM THEIR DEVICE BECAUSE THEY THOUGHT IT SHOULD BE DONE PERIODICALLY, BUT THERE WERE NO ISSUES WITH THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THE INTERMITTENT SHOCKING WHICH CAUSED ¿OUC \HING¿ AND THE CONSUMER ¿ALMOST GOING OUT OF THEIR SKULL¿ WAS A CHANGE OF BATTERIES. THE INTERMITTENT SHOCKING WAS NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724629 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR