BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2518524 · Received April 5, 2012

    Report

    Report Number
    3004209178-2012-02146
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL # 37744, LOT # NKT018976N; RECHARGER MODEL # 37754, LOT # NKU014808N; EXTENSION MODEL # 3708140, LOT # NJB005542V, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN; EXTENSION MODEL # 3708140, LOT # NJB006934V, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN; LEAD MODEL # 377845, LOT # V009444, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN; LEAD MODEL # 377845, LOT # V010933, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    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 UNDERWENT A POCKET REVISION, NOT FURTHER SPECIFIED. THE INS WAS 6 YEARS OLD. THE PATIENT AND PHYSICIAN DECIDED TO CHANGE OUT INS AT THE SAME TIME AS POCKET REVISION. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    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 00065 YR Required Intervention