BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3141395 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-03692
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 13, 2011
    Report Date
    April 29, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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: 1627487-2013-03691. THE PATIENT RECEIVED 2 MODEL 3146 SCS LEADS WITH THE SAME LOT NUMBER. THE PATIENT REPORTED SHE WOULD LIKE HER SCS SYSTEM EXPLANTED DUE TO NEVER RECEIVING EFFECTIVE STIMULATION. THE PATIENT IS TO CONSULT WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232333 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3146 3158107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE: