BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7241831 · Received February 5, 2018

    Report

    Report Number
    3004209178-2018-02095
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    January 20, 2018
    Report Date
    February 5, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS OVERDISCHARGED. THE REPRESENTATIVE MET WITH THE PATIENT LAST MONTH BECAUSE OF A SUSPECTED OVERDISCHARGE- THE DEVICE HAD BEEN OVERDISCHARGED ON TWO OTHER OCCASIONS. THE PATIENT HAD RECHARGED THEIR DEVICE BUT THE REPRESENTATIVE WAS UNABLE TO COMMUNICATE WITH THEIR INS WITH THE CLINICIAN PROGRAMMER, PATIENT PROGRAMMER, AND RECHARGER. IT WAS NOTED THAT THE RECHARGER WAS BROKEN AT THE CONNECTION PORT. THE PATIENT COMPLAINED THAT THE DEVICE WASN'T WORKING PROPERLY AFTER THE PREVIOUS OVERDISCHARGES AND IT WAS EXPLAINED THAT THE BATTERY LIFE AND CAPACITY COULD BE GREATLY REDUCED AFTER THE OVERDISCHARGES. THEIR HEALTHCARE PROVIDER WAS GOING TO TRY AND SCHEDULE THEIR SURGERY IN THE NEXT TWO TO FOUR WEEKS. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84748 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention