BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW DUAL 16 CHANNEL RF RECEIVERS

    MDR report key: 2193122 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03303
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 AN SCS SYS ON (B)(6) 2005. IT WAS REPORTED THAT THE PT CAN FEEL STIMULATION BUT IT IS VERY WEAK. THE TRANSMITTER READ SYS ERROR OF "OCO3." A REPLACEMENT TRANSMITTER WAS SENT. BUT, THEY WERE NOT ABLE TO COMMUNICATE OR PROGRAM WITH THE NEW TRANSMITTER. THE DOCTOR IS PLANNING TO REPLACE THE OLD RF SYS WITH A RECHARGEABLE IPG. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW DUAL 16 CHANNEL RF RECEIVERS RADIO-FREQUENCY RECEIVER LGW ST. JUDE MEDICAL - NEUROMODULATION 3416 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186