BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2876068 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11929
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    September 15, 2012
    Report Date
    November 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 377760 LOT# V010175, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377760 LOT# V010175, IMPLANTED: 2006 (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 THAT A PATIENT EXPERIENCED DISCOMFORT AT THE CONNECTION SITE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEADS. EXAMINATION AND PALPITATION OF THE AREA WAS DONE ON (B)(6) 2012 AND IT WAS REPORTED TO BE UNCOMFORTABLE. THE INS WAS SURGICALLY REPOSITIONED ON (B)(6) 2012. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES. ONE LEAD WAS BROUGHT DOWN SO THAT ITS UPPER TWO CONTACTS WERE IN THE MIDDLE OF THE OPPOSING LEAD'S CONTACT ARRAY. AFTER THE LEAD WAS REPOSITIONED THERE WERE NO HIGH IMPEDANCES ON THE TWO UPPER CONTACTS. IT WAS ALSO REPORTED THAT THE EXTENSION WAS REPLACED. THERE WAS ALSO REPROGRAMMING CONDUCTED ON (B)(6) 2012. THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS ONGOING WITH NO FURTHER ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED BY THE PATIENT THAT IN (B)(6) 2012, THINGS GOT WORSE AND HIS PHYSICIAN MOVED THE "LEAD" TO HIS STOMACH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention