BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2751187 · Received September 19, 2012

    Report

    Report Number
    3004209178-2012-08270
    Event Type
    Injury
    Date Received
    September 19, 2012
    Report Date
    August 24, 2012
    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

    PRODUCT ID 3708120, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3708120, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3487A-33, LOT# V001984, SERIAL# IMPLANTED: (B)(6) 2006,EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3487A-33, LOT# V001437, SERIAL# IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3272-51, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, EXPLANTED: (B)(6) 2007, PRODUCT TYPE RECEIVER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED BECAUSE OF LEAD MIGRATION, NOT AN INFECTION. ADDITIONAL REVIEW DETERMINED THAT THIS EVENT WAS ALREADY REPORTED UNDER MFR. REP. # 3004209178-2012-06737. ALL FUTURE FOLLOW-UP WILL BE REPORTED UNDER THAT MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYSTEM WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention