BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2991244 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03388
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    March 14, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-56 LOT# V369178, IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-56 LOT# V398029, IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37082-40 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3550-39 LOT#, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-39 LOT#, PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-39 LOT#, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF LEAD (B)(4) REVEALED A BROKEN CONDUCTOR AT THE DISTAL END. ANALYSIS OF THE REMAINING TWO LEADS REVEALED NO ANOMALY. ANALYSIS OF THE LEAD ANCHORS REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE LEAD S/N (B)(4) FOUND A RELIABILITY NON-CONFORMANCE. ANALYSIS OF THE LEAD L/N V369178 FOUND NO ANOMALY. ANALYSIS OF THE LEAD L/N (B)(4) FOUND NO ANOMALY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD THREE LEADS REMOVED BECAUSE THE PATIENT DESIRED REMOVAL AND DECLINED FURTHER EFFORTS TO IMPLANT A NEW IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THIS WAS AN ELECTIVE REMOVAL OF THE LEADS AND THERE WERE NO ISSUES WITH THE LEADS. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS WERE EXPLANTED FOR AN UNKNOWN REASON. THE PATIENT WAS REPORTED TO HAVE "RECOVERED WITHOUT SEQUELAE." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96292 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