BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7440603 · Received April 18, 2018

    Report

    Report Number
    3004209178-2018-08325
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 2, 2018
    Report Date
    October 5, 2018
    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
    FL, 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

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

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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 WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF COMPLEX REG PAIN SYNDROME TYPE I AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS TRYING TO CHARGE AND ¿IT WON'T LET THEM CHARGE.¿ NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2018-SEP-18. IT WAS REPORTED THAT THE REP MET WITH THE PATIENT TO PROVIDE RE-EDUCATION ON CHARGING. THE REP THEN NOTED THAT THE CAUSE OF THE INABILITY TO CHARGE WAS DUE TO THE FACT THAT THE PATIENT FORGOT HOW TO CHARGE. IN THE END, THE CHARGING ISSUE RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S IMPLANT HAD DIED AND SHE MET WITH A MANUFACTURER'S REPRESENTATIVE (REP) AT HER HEALTHCARE PROVIDER'S OFFICE ON WEDNESDAY. PATIENT SATED THE REP STARTED CHARGING IT AND GOT IT TO 25% THEN SENT THE PATIENT HOME WITH INSTRUCTIONS TO CHARGE IT UNTIL 100% CHARGED AND TO NOT USE IT. PATIENT STATED WHEN SHE GOT HOME SHE WAS NOT ABLE TO CHARGE IT. PATIENT WAS WONDERING IF SOMETHING WAS WRONG WITH HER OTHER EQUIPMENT. PATIENT STATED SHE WANTED TO MEET UP WITH THE REP AGAIN. NO SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284419 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR