BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW RECEIVER, 16-CHANNEL

    MDR report key: 2191566 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06018
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT RECEIVED A NEUROSTIMULATOR RECEIVER ON (B)(6) 2001. IT WAS REPORTED THAT SHE IS EXPERIENCING DIFFICULTY COMMUNICATING WITH THE DEVICE VIA HER TRANSMITTER ANTENNA. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW ANTENNA WAS SHIPPED TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME AS ALL ATTEMPTS TO CONFIRM RESOLUTION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER, 16-CHANNEL SPINAL CORD STIMULATION RECEIVER GZB ST JUDE MEDICAL - NEUROMODULATION 3416 118191A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS LEADS: MODEL 3186 (2)| IMPLANTED: