BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2040288 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-00341
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 2 OF 2. REFERENCE MFR. REPORT # 1627847-2011-00340 THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2011 INCLUDING AN IPG AND SURGICAL LEAD FOR BLADDER PAIN (OFF-LABEL LOCATION). IT WAS REPORTED THAT HER STIMULATION IS FUNCTIONING INTERMITTENTLY. EFFORTS TO RECTIFY THIS MATTER VIA REPROGRAMMING HAVE BEEN UNSUCCESSFUL THUS FAR. FOLLOW-UP ON THE PATIENT FOUND THAT AT HER MOST RECENT PROGRAMMING SESSION SHE WAS GIVEN SEVERAL NEW PROGRAMS WHICH PROVED TO BE COMFORTABLE OPTIONS FOR HER. NO FURTHER INTERVENTION WILL BE TAKEN AT THIS TIME AS THIS SITUATION WILL CONTINUE TO BE MONITORED.

    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 3246147

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR