BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3607893 · Received November 4, 2013

    Report

    Report Number
    1627487-2013-21246
    Event Type
    Injury
    Date Received
    November 4, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-21268. IT WAS REPORTED THE PATIENT WAS RECEIVING INEFFECTIVE STIMULATION. PER THE MANUFACTURER'S RECORDS, THE PATIENT REC'D A MEW SCS LEAD AND IPG. IT IS UNKNOWN AT THIS TIME IF THE PENTA LEAD WAS EXPLANTED. THE REASON FOR EXPLANTING AND REPLACING THE IPG IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567757 PENTA GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3228 3726672

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS EXTENSION, MODEL 3383 (2)| IMPLANT DATE: