BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1921701 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12652
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "HIGH RESISTANCE/IMPEDANCE". MAX RV PACE IMPEDANCE ROSE FROM 551 OHMS TO 741 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE ANALYSIS ALSO REVEALED "OVERSENSING: 8 NSTS WITH AVERAGE V-V CYCLES <220 MS RECORDED BETWEEN (B)(6) AND (B)(6) 2010" AND "INTERFERENCE/NOISE: 270 V-SI COUNTS IN LAST 55 DAYS (SINCE LAST SESSION), AVERAGE OF 4.9/DAY. 0 V-SI COUNTS IN 46 DAYS PRIOR TO LAST SESSION".

    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: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "HIGH RESISTANCE/IMPEDANCE". MAX RV PACE IMPEDANCE ROSE FROM 551 OHMS TO 741 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE ANALYSIS ALSO REVEALED "OVERSENSING: 8 NSTS WITH AVERAGE V-V CYCLES <220 MS RECORDED BETWEEN (B)(6) AND (B)(6) 2010" AND "INTERFERENCE/NOISE: 270 V-SI COUNTS IN LAST 55 DAYS (SINCE LAST SESSION), AVERAGE OF 4.9/DAY. A 0 V-SI COUNTS IN 46 DAYS PRIOR TO LAST SESSION".

    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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "HIGH RESISTANCE/IMPEDANCE". MAX RV PACE IMPEDANCE ROSE FROM 551 OHMS TO 741 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE ANALYSIS ALSO REVEALED "OVERSENSING: 8 NSTS WITH AVERAGE V-V CYCLES <220 MS RECORDED BETWEEN (B)(6) AND (B)(6) 2010" AND "INTERFERENCE/NOISE: 270 V-SI COUNTS IN LAST 55 DAYS (SINCE LAST SESSION), AVERAGE OF 4.9/DAY. 0 V-SI COUNTS IN 46 DAYS PRIOR TO LAST SESSION".

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LEFT VENTRICULAR LEAD THERE WAS HIGH THRESHOLD, LOSS OF CAPTURE AND NOISE, AS WELL AS A POSSIBLE DISLODGEMENT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING, THAT THERE WAS NOISE AND INCREASING IMPEDANCE AND THAT THE LEAD INTEGRITY ALERT TRIGGERED. IT WAS FURTHER REPORTED THAT THE LEAD HAD INCREASING IMPEDANCE, TO OUT OF RANGE AND THAT NOISE WAS NOTED TO BE PRESENT ON THE ELECTROGRAM. BOTH LEADS AND THE DEVICE REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LEFT VENTRICULAR LEAD THERE WAS HIGH THRESHOLD, LOSS OF CAPTURE AND NOISE, AS WELL AS A POSSIBLE DISLODGEMENT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING, THAT THERE WAS NOISE AND INCREASING IMPEDANCE AND THAT THE LEAD INTEGRITY ALERT TRIGGERED. BOTH LEADS REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEAD HAD INCREASING IMPEDANCE, TO OUT OF RANGE AND THAT NOISE WAS NOTED TO BE PRESENT ON THE ELECTROGRAM. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED AND WAS REVISED. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LEFT VENTRICULAR LEAD THERE WAS HIGH THRESHOLD, LOSS OF CAPTURE AND NOISE, AS WELL AS A POSSIBLE DISLODGEMENT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING, THAT THERE WAS NOISE AND INCREASING IMPEDANCE AND THAT THE LEAD INTEGRITY ALERT TRIGGERED. BOTH LEADS REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB