BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3933976 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13003
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REVISION, THE PATIENT COMPLAINED OF ELECTRIC LIKE SHOCKS WHEN STIMULATION WAS TURNED UP TO THE LOWEST LEVEL. AN XRAY SHOWED THAT BOTH PERCUTANEOUS LEADS WERE ANTERIOR. IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. THE PATIENT WILL BE SENT TO A SURGEON FOR SURGICAL LEAD PLACEMENT. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY. IT WAS FURTHER REPORTED THAT THE PATIENT¿S STIMULATOR WAS OFF AND THEY WERE DOING FINE. IT WAS ALSO STATED THE PATIENT WAS ADVISED TO KEEP THE STIMULATOR RECHARGED. SEE MFR 3004209178-2014-12868 FOR THE PREVIOUS REVISION MENTIONED.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED BY THE SURGEON THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION FOR A PADDLE LEAD (DATE NOT PROVIDED). THE ISSUE WAS CONSIDERED ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412352 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention