BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6116400 · Received November 21, 2016

    Report

    Report Number
    3004209178-2016-24419
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    December 9, 2014
    Report Date
    November 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT THAT THE PATIENT DID NOT THINK HER DEVICE WAS WORKING RIGHT. THE LAST TIME SHE HAD THE DEVICE ON THE PATIENT¿S LEGS HURT REALLY BADLY AND IT FELT LIKE IT WAS HER MUSCLES. IT ALSO TOOK THE PATIENT A WHILE TO STAND. THE PATIENT JUST MOVED TO (B)(6) AND HER PATIENT PROGRAMMER AND RECHARGER WERE PACKED AND ARE IN STORAGE WHICH THE PATIENT HAD NO ACCESS TO. IT WAS NOTED THAT THE PATIENT VISITED THE MANUFACTURER ABOUT TWO WEEKS PRIOR TO (B)(6) 2016 AND THEY COULDN¿T PULL UP HER INFORMATION IN THEIR SYSTEM. THE PATIENT HAD AN APPOINTMENT WITH A HEALTHCARE PROFESSIONAL AT A PAIN CLINIC ON (B)(6) 2016 AND WANTED A MANUFACTURER REPRESENTATIVE (REP) TO BE PRESENT. THE ISSUE BEGAN IN (B)(6) OF 2016. IT WAS NOTED THAT THE PATIENT WAS WORKING TO GET A NEW HEALTHCARE PROFESSIONAL. IT WAS ALSO NOTED THAT THE PATIENT LIVED IN A HOMELESS SHELTER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT DIDN¿T KNOW IF HER IMPLANT WOULD TURN ON BECAUSE IT HAD BEEN OF FOR A WEEK AS OF (B)(6) 2016. THE PATIENT WANTED TO ORDER A REPLACEMENT PROGRAMMER AND RECHARGER AS SHE HAD LOST BOTH. IT WAS NOTED THAT THE PATIENT HAD A STOMACH SURGERY THAT GOT HER DOWN TO WEIGHING (B)(6). A DOCTOR TOLD THE PATIENT TO GET DOWN TO (B)(6) AND THEN SHE COULD CONSIDER GETTING A BREAST REDUCTION. THE PATIENT WAS TO CALL THE MANUFACTURER BACK FOR SHIPPING INFORMATION FOR THE REPLACEMENT DEVICES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE PATIENT TO CHARGE BECAUSE OF WHERE THE INS WAS LOCATED. IT WAS HARD TO KEEP THE ANTENNA IN PLACE WHEN CHARGING AND THE PATIENT WISHED THAT THE INS WAS IMPLANTED IN THE FRONT. THE PATIENT ASKED ABOUT THE POSSIBILITY OF GETTING A NON-RECHARGEABLE BATTERY WHEN IT WAS TIME TO GET THE CURRENT ONE REPLACED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE DEVICE HAD BEEN OFF FOR TOO LONG. SHIPPING INFORMATION FOR THE REPLACEMENT DEVICES WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769416 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR