BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATRODE

    MDR report key: 2980221 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02266
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 3. REFERENCE MFR REPORTS # 1627487-2013-02265 AND 1627487-2013-02267. THE PT HAS TWO SCS SYSTEMS, INCLUDING 10 LEADS FROM 3 SEPARATE LOTS. IT WAS REPORTED THE PT'S INCISION IN HIS MID-BACK AREA HAD OPENED UP. THE PT WAS GIVEN DOXYCYCLINE. THE PHYSICIAN TOOK THE PT TO SURGERY ON (B)(6) 2013 IN ORDER OT CLEAN AND CLOSE THE WOUND. IT WAS REPORTED THE PT PLANS TO SEE THE PHYSICIAN FOR A FOLLOW-UP VISIT. NO FURTHER INO IS AVAILABLE AT THIS TIME. AS THE AFFECTED LEADS ARE UNKNOWN, ALL OF THE PT'S LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78125 QUATRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3724365

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention SCS EXTENSION: MODEL 3346 (2)| IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (2)| SCS EXTENSION: MODEL 3346 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS EXTENSION: MODEL 3346 (2)