BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2744116 · Received September 13, 2012

    Report

    Report Number
    3004209178-2012-08105
    Event Type
    Injury
    Date Received
    September 13, 2012
    Report Date
    August 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT# V008386, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3982, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE LEAD; PRODUCT ID 377875, LOT# V011888, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVER-DISCHARGED. IT WAS REPORTED THAT THE PATIENT'S COMPLIANCE WAS THE PRIMARY REASON FOR OVER-DISCHARGE, BUT IT ALSO WAS REPORTED THAT THE PATIENT HAD COUPLING AND/OR COMMUNICATION ISSUES. THIS WAS THE PATIENT'S THIRD OVER-DISCHARGE, AND IT WAS NOTED THE INS NEEDED TO BE REPLACED. 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention