BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3034635 · Received April 4, 2013

    Report

    Report Number
    3004209178-2013-04598
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 16, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377760 LOT# V010176, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 377760 LOT# V010175, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID: 37742 LOT# SERIAL# (B)(4) IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD LEFT SHIN PAIN WHICH BEGAN APPROXIMATELY ONE MONTH POST BACK SURGERY (B)(6) 2012 AND NO ONE KNEW WHAT WAS CAUSING IT, THE PATIENT DID NOT BELIEVE IT WAS RELATED TO HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO STATED, THE PATIENT THOUGHT HER ENTIRE INS SYSTEM HAD BEEN EXPLANTED BUT THE MANUFACTURER'S RECORDS DID NOT CONFIRM THAT. IT WAS THEN REPORTED ON (B)(6) 2013 THAT THE PATIENT STATED, HER INS WAS REMOVED "IN FULL". IT WAS STATED THAT THE PATIENT'S INS AND LEADS WERE REMOVED IN (B)(6) 2012 BECAUSE, IT WASN'T "WORKING WELL ENOUGH AND THE PATIENT HAD A PUMP IMPLANTED THAT WAS DOING A BETTER JOB OF TREATING HER PAIN". THE PATIENT WANTED AN X-RAY TO PROVE THE DEVICE WAS REMOVED THEN WANTED TO HAVE AND MRI. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138678 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