BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7280787 · Received February 19, 2018

    Report

    Report Number
    3004209178-2018-03565
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    January 23, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. ANALYSIS FOUND BROKEN CONNECTOR PINS ON THE DESKTOP CHARGER (SERIAL #(B)(4)). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37761 (B)(4) PRODUCT TYPE RECHARGER (B)(4) APPLIES TO THE DESKTOP CHARGER/RECHARGER (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE PATIENT REPORTED THE DEVICE HELPED THEM BE ABLE TO MOVE AGAIN. THE REPLACEMENT DESKTOP CHARGER RESOLVED THE BROKEN CONNECTOR PIN AND PAIN SYMPTOMS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THERE WAS A BROKEN CONNECTOR PIN ON THE DESKTOP CHARGER. THE PATIENT SAID THE METAL TIP BROKE OFF THE CONNECTOR PIN. THE PATIENT WAS ABLE TO TAKE THE METAL TIP OUT OF THE RECHARGER AND NOW THE METAL TIP WAS IN TWO PIECES. THE PATIENT ALSO REPORTED PAIN SYMPTOMS THAT STARTED SHORTLY AFTER THE CONNECTOR PIN BROKE. NO OUT-OF-BOX FAILURES OR FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123395 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR