BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4122820 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17831
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-56, LOT# VA0AHEN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 399930, LOT# J0555196V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3487A-56, LOT# VA0AHEN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 74002, LOT# N205624, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER; PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 399930, LOT# J0555196V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PAIN AROUND THE EXTENSION SITE AND HAD FELT A ¿POP¿ ON THE WEEKEND PRIOR TO THE DATE OF THIS REPORT AND THE STIMULATION HAD MOVED BACK IN THE PATIENT¿S CHEST. X-RAYS WERE TAKEN AND SHOWED THAT ONE OF THE PATIENT¿S LEADS HAD SLIPPED DOWN INTO THE THORACIC SPINE. IT WAS UNKNOWN WHICH LEAD HAD MIGRATED. THE STIMULATOR WAS REPROGRAMMED AND THE PATIENT RECEIVED ADEQUATE COVERAGE. THE PATIENT HAD BEEN RECEIVING EFFECTIVE THERAPY SINCE THE DEVICE WAS IMPLANTED. AN EXPLANT WAS NOT GOING TO BE DONE. IT WAS UNKNOWN WHAT HAD CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601672 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR