BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7280930 · Received February 19, 2018

    Report

    Report Number
    3004209178-2018-03573
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    February 1, 2018
    Report Date
    May 31, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# V013787, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. 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 REGARDING THEIR NEUROSTIMULATOR (INS) THAT WAS IMPLANTED FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT PATIENT WAS NOT FEELING WHAT HE USED TO FEEL BEFORE, HE WAS NOT FEELING STIM. THEY HAD TRIED CHANGING PROGRAMS/GROUPS/INTENSITY AND WAS STILL NOT FEELING STIM AT ALL. CALLER WANTED TO MEET WITH A MANUFACTURER REP FOR REPROGRAMMING. IT WAS CONFIRMED THOROUGH THE PATIENT PROGRAMMER THAT PATIENT'S THERAPY WAS ON. CALLER WAS REDIRECTED TO THEIR HCP. AN EXACT DATE OF WHEN THE EVENT OCCURRED WAS NOT PROVIDED. PATIENT REPORTED MAYBE IN (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT THE CIRCUMSTANCES THAT LED TO NOT FEELING STIMULATION WAS THAT THE PADDLES NEEDED REPLACED. THE PATIENT REPORTED THAT HE MET WITH A MANUFACTURER¿S REPRESENTATIVE (REP). THE PATIENT REPORTED THAT HE WAS NOW FEELING STIMULATION AND HAD SURGERY TO REMOVE THE OLD AND PUT IN NEW PADDLES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123286 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention