BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4163518 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19449
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT# J0217084V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 74002, LOT # N423896, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ADAPTER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT # J0222848V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY SHOWED THE LEAD AND EXTENSION HAD MIGRATED DOWN TO THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. THE PATIENT DID NOT FEEL STIMULATION WHEN TESTING THIS LEAD. THERE WAS LOW IMPEDANCE ¿TWO.¿ DIAGNOSTIC TESTING OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING, X-RAYS AND REPROGRAMING. THE PRODUCT STATUS OF THE LEAD AND EXTENSION WAS IMPLANTED AND OUT OF SERVICE. THE EVENT OCCURRED DURING NORMAL USE. IT WAS UNKNOWN IF ACTIONS WERE REQUIRED AS A RESULT OF THE EVENT. IT WAS UNKNOWN IF THERE WERE SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. IT WAS UNKNOWN IF A REVISION OR REPLACEMENT HAD BEEN SCHEDULED. THE CAUSE OF EVENT WAS NOT DETERMINED. THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640649 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1