BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PULSE GENERATOR

    MDR report key: 2810500 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03670
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    June 21, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CORRECTION: REDACTION OF FDA REPORT NUMBER 2182208000201202758. A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED TO INDICATE THE EVENT FOR THE REFERENCED FDA REPORT NUMBER WAS INADVERTENTLY SUBMITTED UNDER THE MEDICAL DEVICE REPORTING REGULATIONS. INFORMATION WAS SUBSEQUENTLY RECEIVED REPORTING THE ISSUE WAS CAUSED BY THE IPG (IMPLANTABLE PULSE GENERATOR), AND THERE WAS NO ISSUE WITH THE MODEL 2090W PROGRAMMER. WITHOUT A DEVICE SERIAL NUMBER FOR THE IPG, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE AFTER THRESHOLD TESTING OR SENSING OF AN IMPLANTABLE PULSE GENERATOR (IPG). A SECOND PROGRAMMER WAS THEN USED AND DISPLAYED THE SAME ERROR MESSAGE. ADDITIONAL INFORMATION RECEIVED REPORTED THE ISSUE WAS CAUSED BY A "FLIPPED BIT" OF THE IPG, AND A MANUAL GUIDED RESET (MGR) WAS RECOMMENDED TO RESTORE THE IPG FROM THIS CONDITION. NO ACTION WAS TAKEN, AND EVALUATION AT THE PATIENT'S NEXT VISIT IN APPROXIMATELY THREE MONTHS WILL BE CONDUCTED TO DETERMINE NECESSARY ACTION (POSSIBLE IPG CHANGE OUT OR MGR). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC, INC. IPG/VIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other