BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2433246 · Received January 31, 2012

    Report

    Report Number
    3004209178-2012-00650
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    May 26, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3998, LOT # V011699, IMPLANTED: (B)(6) 2010, EXPLANTED: UNK. LEAD: MODEL 3998, LOT# V062321V01, IMPLANTED: (B)(6) 2010, EXPLANTED: UNK. EXTENSION: 3708260, SERIAL (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011. EXTENSION: 3708260, SERIAL (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK-BASED ANALYSIS CRITERIA.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED DUE TO INFECTION. THE DEVICE WS NOT REPLACED. PATIENT DEATH DID NOT OCCUR, BUT OUTCOME WAS NOT KNOWN. ADDITIONAL INFORMATION FROM THE PATIENTS PHYSICIAN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention