BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE 8 EXTENSION, 60 CM

    MDR report key: 2251255 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-01931
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 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

    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01932. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND EXTENSION, ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAD FALLEN AND SUBSEQUENTLY LOST STIMULATION. IT WAS ALSO REPORTED THAT THE IPG SITE WAS CAUSING DISCOMFORT FOR THE PT DUE TO ITS LOCATION AND SIZE. THE PHYSICIAN TOOK THE PT TO SURGERY ON (B)(6) 2011 AND NOTED A FRACTURE AT THE EXTENSION; HOWEVER, THE LEAD SHOWED NO ANOMALIES. THE PHYSICIAN EXPLANTED THE EXTENSION AND IPG. THE IPG WAS REPLACED WITH A SMALLER MODEL, AND THE POCKET SITE WAS MOVED TO AN ALTERNATE LOCATION. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE. THE FACILITY WOULD NOT RELEASE THE EXPLANTED DEVICES; THEREFORE, THEY WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION, 60 CM SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 86049

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT: