BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A127 LEAD ADAPTER

    MDR report key: 2121031 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-01636
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01635. IT WAS REPORTED THAT THE PT HAD A MEDTRONIC LEAD THAT WAS IMPLANTED AT AN UNK TIME, AND IT WAS CONNECTED TO A SJM IPG VIA A LEAD ADAPTER. THE PT ALLEGEDLY LOST STIMULATION AND REPORTED DISCOMFORT AT THE IPG POCKET SITE. AN X-RAY SHOWED NO ANOMALIES WITH THE SCS SYSTEM. THE PHYSICIAN EXPLANTED THE PT'S SYSTEM AND REPLACED IT WITH A SURGICAL LEAD AND SMALLER MODEL IPG ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A127 LEAD ADAPTER SPINAL CORD STIMULATION LEAD ACCESSORY LGW ST. JUDE MEDICAL - NEUROMODULATION 2342 R45713

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention