BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6609249 · Received June 2, 2017

    Report

    Report Number
    3004209178-2017-11561
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Report Date
    September 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW DETERMINED THAT THE FOLLOWING PREVIOUSLY REPORTED CONCOMITANT PRODUCT: PRODUCT ID (B)(4) SERIAL# (B)(4), PRODUCT TYPE RECHARGER, IS NOT ELIGIBLE FOR REGULATORY REPORTING. FDD CODES ASSIGNED TO THE RECHARGER (B)(4) NO LONGER APPLY; THESE CODES ARE (B)(4). 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97754, (B)(4), PRODUCT TYPE: RECHARGER. 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 IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT A PATIENT WAS NOT PLEASED WITH HOW THINGS WERE GOING WITH THEIR DEVICE. IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE ENOUGH PATIENT EDUCATION. THE PATIENT WENT IN TO THE HEALTHCARE PROVIDER¿S OFFICE TO GET STITCHES REMOVED AND STATED THAT THEIR DEVICE WENT OUT ON HER WHEN SHE WAS AT HOME AFTER SURGERY. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS HAVING PROBLEMS GETTING THE 6 BARS. THE PATIENT SAID THE REP WAS PUSHING AND PRODDING TO GET THE 6 BARS. THE PATIENT STATED THEY WERE RECHARGING MORE THAN EXPECTED. THE PATIENT STATED THEY WERE NEVER TOLD HOW DIFFICULT IT WOULD BE TO RECHARGE THEIR DEVICE OR HOW MUCH EQUIPMENT THEY WOULD NEED TO CHARGE THE DEVICE. THE PATIENT STATED THEY WANTED THE DEVICE REMOVED. THE PATIENT MENTIONED SHE IS BIPOLAR AND HAVING TO REMEMBER EVERYTHING AS FAR AS USING HER DEVICE IS TOO MUCH FOR HER. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THAT THEIR INS RECHARGER (INSR) WAS GOING "IN AND OUT" AND THEY THINK THEY NEED A NEW ONE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE INSR HAD A LOOSE CONNECTOR PIN AND WHEN THE CONNECTOR WAS WIGGLED, THE POWER CHARGER WAS DROPPED. THE CONNECTOR WAS DAMAGED AND THERE WAS NO INDICATION OF PATIENT HARM. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389693 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1