BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2821124 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-12385
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    IT WAS REPORTED THE PT HAD AUTO-REDUCTION OF AMPLITUDE. THE SJM REP INTERROGATED THE SYSTEM AND FOUND LOW IMPEDANCES ON ALL CONTACTS. IMAGES WERE TAKEN AND SHOWED NO ANOMALIES. FOLLOW UP DETERMINED THE PT REPORTED AUTO-REDUCTION LESS THAN TWELVE HOURS AFTER REPROGRAMMING. FURTHER FOLLOW-UP IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3228 3643187

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXT: MODEL 3383 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192