BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 2206396 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01700
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WAS A LEAD INTEGRITY ALERT ON (B)(6) 2011 04:54:54. THERE WERE ALSO 2 - PATIENT ALERTS FOR HIGH IMPEDANCE, WITH THE RV PACE LEAD Z=1032 OHMS (B)(6) 2011 03:00:03 AND RV PACE LEAD Z=1008 OHMS (B)(6) 2011 03:00:03. THE WEEKLY PACE MEASUREMENT LOG DATA SHOWS AN ABRUPT INCREASE FOR MAX V.PACE= 528 TO 1408 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2011. THERE WAS ALSO SENSING - OVERSENSING WITH 41 - VENTRICULAR NON-SUSTAINED TACHYCARDIAS <=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 03:00:04 AND (B)(6) 2011 02:42:12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR SENSING INTEGRITY COUNT AND IMPEDANCE OUT OF RANGE. THE FOLLOW-UP INFORMATION INDICATED THAT THERE WAS A PLAN TO REPLACE THE LEAD WITH A NEW LEAD, WITHIN THE NEXT COUPLE OF WEEKS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R