BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3943720 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13224
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 9 77A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN, LOT# UNKNOWN ANCHOR, PRODUCT TYPE: UNKNOWN; PRODUCT ID NEU_STYLET_ACC, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DIFFICULTY ENCOUNTERED WHILE ADVANCING THE LEAD. IT WAS NOTED THAT DURING A REVISION ON (B)(6) 2014 THE HEALTH CARE PROVIDER (HCP) WAS NOT ABLE TO ADVANCE ONE OF THE LEADS. IT WAS REPORTED THEY WERE NOT ABLE TO GET THE STYLET IN THE LEAD. IT WAS NOTED THE STYLET ONLY ¿WENT IN 1-2 INCHES¿. IT WAS REPORTED THAT SINCE THE STYLET WOULD NOT ADVANCE IN THE LEAD THAT IT WAS EXPLANTED AND REPLACED. IT WAS REPORTED AN IMPEDANCE CHECK WAS PERFORMED AND WAS FINE.**INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ ANCHOR AND LEAD MIGRATION. THESE EVENTS ARE NOT REPORTABLE**

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE SAW THE PATIENT DURING THE WEEK OF THE REPORT AND THEIR THERAPY IS WORKING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421588 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR