BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2931052 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01017
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778, LOT# V640499018, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778, LOT# V648088004, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE DEVICE REVEALED THE FOLLOWING: LEAD ((B)(4)) NO ANOMALY FOUND. FINAL ANALYSIS OF THE DEVICE REVEALED THE FOLLOWING: LEAD ((B)(4)) NO SIGNIFICANT ANOMALY. DISTAL END BY THE CONDUCTOR WAS CUT THROUGH. THE #0 AND #1 ELECTRODE SLEEVES WERE CUT OFF. FINAL ANALYSIS OF THE DEVICE REVEALED THE FOLLOWING: IMPLANTABLE NEUROSTIMULATOR ((B)(4)) - NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PATIENT FALL, THE LEADS MIGRATED OUT OF THE EPIDURAL SPACE. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN USED FOR OVER A YEAR. THE IMPLANTABLE NEUROSTIMULATOR AND LEADS WERE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36897 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