BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2780224 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-12211
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12240. IT WAS REPORTED, THE PT HAD UNWANTED STIMULATION AND SHE HAD PAIN AT THE LEAD INCISION SITE. THE PT REPORTED, HER BRA WAS OVER THE LEAD INCISION. THE PHYSICIAN DETERMINED THE LEAD HAD MIGRATED. IN ADDITION, IT WAS REPORTED, THE PT HAD IRRITABLE BOWEL SYNDROME, AND SHE FELT THE STIMULATION WAS AGGRAVATING THE ISSUE. THE SJM REP MET WITH THE PT FOR REPROGRAMMING AND IT WAS REPORTED, THE UNWANTED STIMULATION WAS RESOLVED. THE PT REPORTED, SHE ALSO HAD PAIN AT THE IPG SITE. F/U IDENTIFIED THE PHYSICIAN PLANNED SURGICAL INTERVENTION TO REPLACE THE TYPE OF LEAD AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3546974

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention