BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECHARGEABLE IPG

    MDR report key: 2210701 · Received July 28, 2011

    Report

    Report Number
    1627487-2011-03368
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D A SCS SYS. IT WAS REPORTED THAT THE PT IS NOT FEELING STIMULATION. HIS PROGRAMMER IS NOT LOCATING THE IPG AND IT IS MAKING A VERY RAPID SHORT BEEPING SOUND WHEN THE PROGRAMMER FIRST TURNS ON AND AFTER THAT IT DOES NOT MAKE ANY OTHER SOUND. PROGRAMMER, WAND AND BATTERY COMPARTMENT REPLACEMENT WERE SENT TO PT, BUT DID NOT RESOLVE THE ISSUE. THE PT IS SCHEDULING AN APPOINTMENT TO MEET WITH HIS PHYSICIAN. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention