BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6591171 · Received May 25, 2017

    Report

    Report Number
    3004209178-2017-11061
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    April 26, 2017
    Report Date
    June 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENT IS: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DESKTOP CHARGER (B)(4) FOUND THAT IT HAD A BROKEN CONNECTOR PIN. ALL FDM AND FDR CODES APPLY TO THE DESK TOP (B)(4). (B)(4) NOW APPLIES TO THE DESKTOP CHARGER (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT DESKTOP CHARGER HAD A BROKEN CONNECTOR PIN AND THE METAL TIP CAME OFF. PATIENT MENTIONED THAT THEY COULDN'T USE THE INS AT THE MOMENT BECAUSE IT WAS DEAD AND THEY NEEDED IT BECAUSE IT REALLY HELPED THEM. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372217 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR