BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3892384 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11989
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3550-39, LOT # N368239, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO CHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THE PATIENT HAD FIRST NOTICED THE ISSUE TWO DAYS PRIOR TO REPORT. THE PATIENT REPORTED THAT IT FELT LIKE HER INS HAD MOVED OR WAS UP TOO HIGH AND THAT SHE COULD NOT GET THE RECHARGING BELT AROUND IT. IT WAS STATED THAT WHEN THE PATIENT CONNECTED WITH THE INS WITH HER RECHARGER AT THE TIME OF REPORT THAT THE NORMAL RECHARGE SCREEN WAS OBSERVED ALONG WITH ZERO COUPLING BARS. IT WAS NOTED THE PATIENT WAS ABLE TO CONNECT WITH THEIR PROGRAMMER AT THE TIME OF REPORT. IT WAS REPORTED THE PATIENT WAS EVENTUALLY ABLE TO RECEIVE 6 COUPLING BARS AT THE TIME OF REPORT AND IT WAS RECOMMENDED THE PATIENT THEN CHARGE THE INS AS MUCH AS SHE WAS ABLE TO. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367885 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR