BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 4348400 · Received December 19, 2014

    Report

    Report Number
    1627487-2014-24414
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    November 26, 2014
    Report Date
    March 6, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 1 OF 7 REFERENCE MFR. REPORT:1627487-2014-24415 REFERENCE MFR. REPORT:1627487-2014-24416 REFERENCE MFR. REPORT:1627487-2014-24417 REFERENCE MFR. REPORT:1627487-2014-24418 REFERENCE MFR. REPORT:1627487-2014-24419 REFERENCE MFR. REPORT: 1627487-2014-24423.

    Description of Event or Problem · 1

    DEVICE 1 OF 6. REFERENCE MFR. REPORT:1627487-2014-24415, REFERENCE MFR. REPORT:1627487-2014-24416, REFERENCE MFR. REPORT:1627487-2014-24417, REFERENCE MFR. REPORT:1627487-2014-24418, REFERENCE MFR. REPORT:1627487-2014-24419. THE PATIENT RECEIVED 6 (OFF-LABEL USE) LEADS. TWO PAIR OF LEADS HAVE THE SAME LOT NUMBER (3724365 AND 4081179). IT WAS REPORTED, THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION AND ONE OF THE LEADS WAS FOUND TO HAVE FLUID INSIDE. IN TURN, MAXIMUM AMPLITUDE COULD NOT BE ACHIEVED. AS A RESULT, ONE OF THE LEADS WAS EXPLANTED AND REPLACED ALONG WITH AN EXTENSION. THE PATIENT REPORTED RECEIVING EFFECTIVE STIMULATION POSTOPERATIVE. ALL DEVICES ARE BEING REPORTED BECAUSE IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    DEVICE 1 OF 7. REFERENCE MFR. REPORT:1627487-2014-24415, REFERENCE MFR. REPORT:1627487-2014-24416, REFERENCE MFR. REPORT:1627487-2014-24417, REFERENCE MFR. REPORT:1627487-2014-24418, REFERENCE MFR. REPORT:1627487-2014-24419, REFERENCE MFR. REPORT:1627487-2014-24423. FURTHER REVIEW OF THE MANUFACTURER'S COMPLAINT DATABASE REVEALED THE REPLACEMENT OF ONE OF THE PATIENT'S IPGS (FOR OFF LABEL USE) RESOLVED THE PATIENT'S ISSUE. THE REPLACEMENT OF THE IPG OCCURRED DURING THE PROCEDURE OF THE LEAD AND EXTENSION BEING REPLACED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835812 QUATTRODE LEAD WIDE SPACED, 60 CM PNS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 3724365

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other MODEL:3789, SCS IPG