BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2023304 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-00348
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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

    THE PATIENT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAS NOT RECEIVED ADEQUATE THERAPY SINCE IMPLANT. HE REPORTEDLY FEELS RELIEF IN HIS LEGS, BUT NOT IN HIS BACK. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING WERE UNSUCCESSFUL. IN ADDITION, NO VISIBLE ANOMALIES WERE OBSERVED WITH THE DEVICE VIA X-RAY. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S LEAD; HOWEVER, STIMULATION HAS NOT BEEN INITIATED SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3164427

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention