BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2982738 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03152
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S STIMULATOR WAS REPLACED ON (B)(6) 2013. THE PATIENT MAY HAVE A PADDLE REVISION DUE TO NOT ENOUGH COVERAGE ON THE RIGHT SIDE. ADDITIONAL INFORMATION REGARDING THIS WAS REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED ONLY THE INFORMATION REGARDING THE IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANT IN FEB (B)(6) PERTAINS TO THIS MANUFACTURER¿S REPORT. ALL OTHER INFORMATION INVOLVING THE LEAD MIGRATION WAS REPORTED IN MFR REPORT # 3004209178-2013-11190. ANY ADDITIONAL INFORMATION NOT RELATED TO THE INS EXPLANT IN 2013 WILL BE REPORTED MFR REPORT # 3004209178-2013-11190.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN OVERDISCHARGE FOR THE PAST TWO YEARS DUE TO PATIENT COMPLIANCE. THE PATIENT EXPERIENCED LACK OF EFFICACY DUE TO LEAD MIGRATION. IT WAS STATED THE BATTERY WILL BE REPLACED AS WELL AS A REVISION ON THE LEAD REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES INFORMATION REPORTED PREVIOUSLY IN MFR # 3004209178-2013-03152 PERTAINS TO MANUFACTURER¿S REPORT # 30042 09178-2013-11190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86815 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention