BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2891218 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12397
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS REVEALED NO ANOMALIES. ANALYSIS OF THE ANCHOR REVEALED THE PRODUCT WAS "SEGMENTED." ANALYSIS OF THE EXTENSION REVEALED THE PRODUCT WAS "CUT THROUGH, SEGMENTED." ANALYSIS OF THE LEAD (LOT # V154338) REVEALED THE FOLLOWING: THE LEAD WAS "BROKEN (OVERSTRESS/DAMAGE)." ANALYSIS OF THE REMAINING TWO LEADS REVEALED THE PRODUCTS WERE "CUT THROUGH, SEGMENTED."

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-56 LOT# V154225, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-45 LOT# V154338, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37082-20 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION/THERAPEUTIC EFFECT WITH LESS THAN 50% THERAPY RELIEF. THE PATIENT REPORTED TO HER HEALTHCARE PROVIDER'S (HCP) OFFICE THE PREVIOUS WEEK BUT SHE WAS UNABLE TO BE HELPED WITH REPROGRAMMING. THE PATIENT ASKED TO HAVE HER SYSTEM EXPLANTED AND HER HCP SCHEDULED HER FOR HER REQUESTED COMPLETE SYSTEM EXPLANT. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention