BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3052898 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-15442
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    April 10, 2012
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15441. THE PT HAS 4 LEADS IMPLANTED (2 FROM ONE LOT AND 2 FROM A DIFFERENT LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT'S STIMULATION HAS BEEN INEFFECTIVE SINCE HER SCS SYSTEM WAS IMPLANTED. THE PT STATED MULTIPLE REPROGRAMMING EFFORTS HAVE BEEN UNSUCCESSFUL. THE PT ALSO STATED THE STIMULATION SHE DOES FEEL IS IN HER EPIDURAL AREA AND SHE NEEDS STIMULATION IN HER LOWER BACK. THE SJM REPRESENTATIVE MET WITH THE PT AND WAS ABLE TO ACHIEVE STIMULATION IN THE CORRECT LOCATION, HOWEVER, THE PT WAS NOT RECEIVING EFFECTIVE PAIN RELIEF FROM THE SCS SYSTEM. DIAGNOSTIC TESTING INDICATED SEVERAL IRREGULAR IMPEDANCES ON THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133477 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3156 3229643

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3341 (2)