BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW SINGLE RECEIVER

    MDR report key: 1963703 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03843
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2001. IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT STIMULATION. THE TRANSMITTER SHOWED A "CONNECT ANTENNA" MESSAGE ALTHOUGH THE ANTENNA HAD BEEN RECONNECTED. A REPLACEMENT ANTENNA AND TRANSMITTER WERE UNABLE TO RESOLVE THE ISSUE. FOLLOW UP ON THE PATIENT FOUND THAT THE NEXT COURSE OF ACTION IS UNDECIDED AT THIS TIME; THE PATIENT IS CONSIDERING A REPLACEMENT WITH AN IPG. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW SINGLE RECEIVER SPINAL CORD STIMULATION RECEIVER GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3416 34012A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention