BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2881443 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-11842
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    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 REPORTED WEAKNESS IN THE LEFT LEG POSTOPERATIVE. THE PT HAD WEAKNESS IN THE LEG PRIOR TO THE PROCEDURE, HOWEVER, THE COMPLAINT WAS THAT THE ISSUE WAS WORSE. THE PHYSICIAN OPTED TO REMOVE THE LEAD AND PLACE THE LEAD IN A SUBCUTANEOUS POSITION. THE SYSTEM HAD NEVER BEEN INITIALIZED OR USED SINCE THE IMPLANT DEVICE. FOLLOW UP FOUND THE PT REPORTED ONLY POSTOPERATIVE PAIN AND NOT WEAKNESS OF THE LEG. IT WAS REPORTED THE PT WAS TO BE SCHEDULED FOR SURGICAL INTERVENTION EITHER TO REMOVE OR REPLACE THE UNUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3333115

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: