BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3904874 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12551
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCATION OF THIS DEVICE IS CURRENTLY UNKNOWN. THIS REPORT WILL BE UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE DEVICE HEADER CONFIRMED THAT ALL SETSCREWS WERE IN THE UP POSITION. BOTH LEADS HAD BEEN CUT AND REMAINED WITHIN THE HEADER, AND THEY WERE CONFIRMED TO BE FULLY INSERTED INTO THE LEAD PORTS. A BROKEN WRENCH TIP WAS NOTED WITHIN THE ATRIAL TIP SETSCREW AND THE SETSCREW WAS HOLLOWED OUT, WHICH WAS CONSISTENT WITH INDUCED DAMAGE FROM A WRENCH THAT WAS LIKELY NOT COMPATIBLE WITH THE DEVICE SETSCREWS. IN THE LABORATORY, A KNOWN COMPATIBLE WRENCH WAS THEN SUCCESSFULLY INSERTED INTO THE OTHER THREE SETSCREW SLOTS (ATRIAL RING, VENTRICULAR TIP, AND VENTRICULAR RING), AND THE WRENCH RATCHETED FREELY AND OPERATED NORMALLY IN BOTH DIRECTIONS WITHIN EACH SETSCREW. EACH LEAD SEGMENT WAS PULLED FROM THE LEAD PORTS WITHOUT ISSUE. VISUAL INSPECTION OF THE SEALING RINGS DID NOT FIND ANY SIGNS OF DAMAGE THAT WOULD INDICATE ADHESION OF THE HEADER TO THE LEADS. THE RIGHT ATRIAL TIP SETSCREW WAS THEN REPLACED IN ORDER TO CONDUCT ADDITIONAL FUNCTIONAL TESTING. THE PACING AND SENSING FUNCTIONS OF THE DEVICE WERE CONFIRMED AND IMPEDANCE TESTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AND NORMAL DEVICE FUNCTION WAS OBSERVED THROUGHOUT ALL TESTS. APART FROM THE INDUCED SETSCREW DAMAGE AND BROKEN WRENCH IN THE ATRIAL TIP SETSCREW, THE SETSCREWS WERE FOUND TO OPERATE NORMALLY, AND BOTH LEADS WERE SUCCESSFULLY (AND EASILY) REMOVED FROM THE HEADER. WHILE AN EVENT OCCURRED ASSOCIATED WITH THIS PACEMAKER, LABORATORY ANALYSIS DID NOT IDENTIFY ANY MALFUNCTION OR OUT-OF-SPECIFICATION CONDITION ASSOCIATED WITH THE SETSCREWS OR THE HEADER THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REVISION PROCEDURE WAS PERFORMED TO EXPLANT THIS PACEMAKER FOR NORMAL BATTERY DEPLETION. HOWEVER, IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DISTAL SETSCREWS COULD NOT BE LOOSENED DURING THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO LOOSEN THE SETSCREWS, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN OPTED TO STOP THE PROCEDURE AND DELAY REPLACEMENT BY ONE DAY. THE PATIENT WAS PACEMAKER DEPENDENT. THE FOLLOWING DAY, THE PHYSICIAN WAS STILL UNABLE TO LOOSEN THE SETSCREWS. THE NON-BOSTON SCIENTIFIC LEADS WERE CUT AND THE PACEMAKER WAS EXPLANTED AND REPLACED WITH A NEW PACEMAKER SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DISTAL SETSCREWS OF THIS PACEMAKER COULD NOT BE FREED DURING A PROCEDURE TO REPLACE THIS DEVICE FOR NORMAL BATTERY DEPLETION. MULTIPLE ATTEMPTS AT MANIPULATING THE SETSCREWS WERE UNSUCCESSFUL. AS SUCH, THE PHYSICIAN OPTED TO STOP THE PROCEDURE AND DELAY REPLACEMENT BY ONE DAY AS THE PATIENT WAS PACEMAKER DEPENDENT. THE FOLLOWING DAY THE PHYSICIAN ATTEMPTED TO LOOSEN THE SETSCREWS AGAIN BUT WAS UNSUCCESSFUL. THE COMPETITOR RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CUT AND SURGICALLY ABANDONED WHILE STILL ATTACHED TO THE DEVICE. A NEW SYSTEM WAS THEN IMPLANTED ON THE PATIENT'S RIGHT SIDE WITHOUT CONSEQUENCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384987 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 1291