BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1013384 · Received March 10, 2008

    Report

    Report Number
    6000144-2008-00051
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 4, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: NO ANOMALIES FOUND. H3 OTHER TEXT : IT WAS REPORTED THAT THERE WERE UNSTABLE IMPEDANCES FOR THE PAST SIX MONTHS. THERE WAS REPORTEDLY AN APPARENT PROBLEM WITH THE RV (RIGHT VENTRICULAR) COIL; IMPEDANCE WAS UNSTABLE, BUT UNABLE TO PRODUCE NOISE ON EGM. HIGH IMPEDANCE WAS ALSO REPORTED, AT GREATER THAN 200 OHMS. DURING SURGERY, THE LEAD WAS FOUND NOT CONNECTED. SEVERAL ATTEMPTS WERE MADE TO SCREW DOWN THE SETSCREW, BUT IT WOULD NOT SECURE THE PIN. THE DEVICE WAS REPLACED, AND THE LEAD WAS LEFT ACTIVE. THE DEVICE WAS SUBSEQUENTLY RETURNED WITH A REPORT OF HVB/SVC IMPEDANCE OUT OF RANGE. THE LEAD PULLED OUT OF THE HEADER WHEN THE POCKET WAS OPENED. MEASUREMENTS NORMALIZED WHEN IT WAS SCREWED BACK IN; HOWEVER, THE LEAD STILL FELL OUT OF THE HEADER WHEN PULLED ON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, 6MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS OPERATIONAL CONTEXT CONTRIBUTED TO EVENT IMPEDANCE, HIGH CONNECTION(S), LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE UNSTABLE IMPEDANCES FOR THE PAST SIX MONTHS. THERE WAS REPORTEDLY AN APPARENT PROBLEM WITH THE RV (RIGHT VENTRICULAR) COIL; IMPEDANCE WAS UNSTABLE, BUT UNABLE TO PRODUCE NOISE ON EGM. HIGH IMPEDANCE WAS ALSO REPORTED, AT GREATER THAN 200 OHMS. DURING SURGERY, THE LEAD WAS FOUND NOT CONNECTED. SEVERAL ATTEMPTS WERE MADE TO SCREW DOWN THE SETSCREW, BUT IT WOULD NOT SECURE THE PIN. THE DEVICE WAS REPLACED, AND THE LEAD WAS LEFT ACTIVE. THE DEVICE WAS SUBSEQUENTLY RETURNED WITH A REPORT OF HVB/SVC IMPEDANCE OUT OF RANGE. THE LEAD PULLED OUT OF THE HEADER WHEN THE POCKET WAS OPENED. MEASUREMENTS NORMALIZED WHEN IT WAS SCREWED BACK IN; HOWEVER, THE LEAD STILL FELL OUT OF THE HEADER WHEN PULLED ON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD