BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2861088 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-12611
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFORMATION 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 WAS NOT RECEIVING STIMULATION. X-RAYS REVEALED THE LEAD MIGRATION. F/U DETERMINED THE PHYSICIAN RELOCATED THE LEAD AND ADD'L ANCHORING WAS PERFORMED. THE LEAD WAS TESTED INTRA-OPERATIVELY ALL IMPEDANCES WERE IN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3741496

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS EXT: MODEL 3386 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788