BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2833468 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10292
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37092, LOT# 301190001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 355531, LOT# N308278, IMPLANTED: 2011 (B)(6), PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HER SYSTEM EXPLANTED THE DAY AFTER THE REPORT. THE CONCERN WAS THAT THE LEADS WERE ERODING THROUGH THE SKIN. ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT'S LEFT SUBCUTANEOUS ANCHOR SITE WAS RED AND WOULD SCAB AND BLEED. THE SYSTEM WAS REMOVED TO PREVENT LEAD EROSION THROUGH THE SKIN AND TO PREVENT INFECTION. THE LEADS WERE SENT TO PATHOLOGY AND THE SURGICAL SITE WAS SWABBED AND SENT TO PATHOLOGY. THE TWO LEADS, ANCHORS, AND DEVICE WERE REMOVED WITHOUT DIFFICULTY. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE SYSTEM WAS ALSO REMOVED BECAUSE IT WAS "NOT HELPING ALLEVIATE THE PATIENT'S BACK PAIN."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WITH THE DEVICE THE PATIENT DIDN¿T GET THE RESULTS THAT SHE WAS LOOKING FOR. IT WAS NOTED THAT THE PATIENT HAD A LEAST TWO REPROGRAMMINGS. THE REPORTER STATED THAT THE PATIENT "SUFFERED" FROM HER EXPERIENCE WITH THE DEVICE. IT WAS REPORTED THAT THE PATIENT HEALED UP FROM THE EXPLANT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention