BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3883868 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11803
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO SYMPTOMS OR THERAPY ISSUES, THE PATIENT JUST WANTED TO HAVE THE DEVICE MOVED FOR COMFORT REASONS. IT WAS STATED THAT THE PATIENT DID NOT SAY WHEN THEY FELT THE NEED TO MOVE THE DEVICE TO A MORE COMFORTABLE LOCATION. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE BECAME AWARE OF THE REVISION ON THE DAY OF THE REVISION. IT WAS STATED THAT NO DIAGNOSTICS WERE DONE. IT WAS REPORTED THAT THE PATIENT WAS DOING GREAT AFTER THE REVISION AND WAS VERY HAPPY WITH THE NEW LOCATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SURGERY FOR POCKET REVISION. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) ACCIDENTALLY NICKED THE LEAD. IT WAS REPORTED THAT IMPEDANCES WERE HIGH. IT WAS REPORTED THAT THE LEAD WAS REPLACED. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AND THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361158 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention