BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3102394 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07424
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 22, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PATIENT HAD HER IMPLANTABLE NEURO STIMULATOR (INS) REMOVED IN (B)(6) 2011, BUT WAS UNCERTAIN OF THE EXACT DATE. IT WAS REPORTED THAT THE LEADS WERE FRACTURED, BUT THEY WERE NEVER ABLE TO DETERMINE HOW THAT OCCURRED OR WHEN. IT WAS STATED THAT IT "MAY" HAVE HAPPENED IN 2008. IT WAS NOTED THAT THE THERAPY HAD "NEVER REALLY HELPED THE PATIENT WITH PAIN". THE PATIENT HAD PAIN IN HER HIPS, LEFT LEG, AND LOWER BACK. THE PATIENT HAD BEEN REPROGRAMMED, BUT "NOTHING REALLY HELPED". IT WAS NOTED THAT THE SHOCKING SENSATION WAS FELT NEAR THE LEAD LOCATION. THE PATIENT HAD ONLY FELT STIMULATION IN THE BACK OF HER LEFT LEG. IT WAS REPORTED THAT THE PATIENT HAD BOTH LEADS AND THE INS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203537 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention