BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7076644 · Received December 1, 2017

    Report

    Report Number
    3004209178-2017-24737
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT WAS NOT MAINTAINING CHARGING. THE REP REPORTED THAT THE BATTERY WAS DISCHARGED AGAIN. THE REP REPORTED THAT THE PATIENT STATED IT WAS DIFFICULT TO CHARGE. THE REP REPORTED THAT THE PATIENT STATED AVERAGE COUPLING BARS 4-5. THE REP REPORTED THAT THEY PERFORMED A TRICKLE CHARGE AND CLEARED THE POWER ON RESET (POR). THE REP REPORTED THAT ALTERNATIVE BATTERY OPTIONS WERE BEING DISCUSSED WITH THE PATIENT AND BWC AND THE PHYSICIAN WOULD DECIDE THE COURSE OF ACTION. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE OF THE DIFFICULTY CHARGING WAS THAT THE PATIENT WAS NON-COMPLAINT. A TRICKLE CHARGE WAS DONE AND THE POWER ON RESET WAS CLEARED. THE DIFFICULTY CHARGING HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856042 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR