BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2153384 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-01693
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 2 OF 3. REFERENCE MFR REPORT: 1627487-2011-01692 AND 1627487-2011-01694. THE PT (B)(6) RECEIVED HIS SCS SYSTEM, INCLUDING FOUR PERCUTANEOUS LEADS (FROM THREE SEPARATE LOTS), ON (B)(6) 2010 FOR SACRAL PAIN. IT WAS REPORTED THAT THE PT LOST STIMULATION. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS FOR ONE OF THE LEADS, AND TWO OTHER LEADS WERE ALLEGEDLY NOT STIMULATING TO THE RIGHT AREA. AN X-RAY WAS TAKEN BUT IT REVEALED NO ANOMALIES. THE PHYSICIAN SUSPECTED A LEAD FRACTURE AND DECIDED TO EXPLANT AND REPLACE ALL FOUR LEADS ON (B)(6) 2011. THE PT REGAINED STIMULATION POSTOPERATIVE, AND NO FURTHER PT COMPLICATIONS WERE REPORTED. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY; THEREFORE, THEY WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3143 2781308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD ANCHOR: MODEL: 1194| IMPLANT:| IMPLANT:| SCS EXTENSION: MODEL: 3341