BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2093559 · Received April 6, 2011

    Report

    Report Number
    1627487-2011-00468
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 # 1627487-2011-00467. THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2011, INCLUDING AN IPG AND A SURGICAL LEAD FOR LOW BACK AND LEG TO KNEE PAIN. IT WAS REPORTED THAT THE PATIENT FEELS A BURNING PAIN AT THE IPG POCKET WHEN HE UTILIZES HIS STIMULATOR FOR MORE THAN 10 MINUTES. OTHERWISE, HIS SCS SYSTEM IS SAID TO BE FUNCTIONING AS INTENDED. IN AN EFFORT TO RESOLVE THIS MATTER, A REPROGRAMMING SESSION WILL BE SCHEDULED FOR THE PATIENT. IN ADDITION, A CULTURE WILL BE TAKEN TO DETERMINE IF THERE IS AN INFECTION AT THE IPG POCKET. AN X-RAY OF THE PATIENT'S SCS SYSTEM WAS ALSO RECOMMENDED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3260894

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention