BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1982845 · Received February 9, 2011

    Report

    Report Number
    2649622-2011-00215
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    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) - NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD IMPEDANCE DROPPED FROM 540 TO 360 OHMS, BUT HAD BEEN STEADY AT 360 OHMS. LEAD THRESHOLDS ON BOTH THE ATRIAL AND VENTRICULAR LEADS HAD BEEN OVER 2.5V. THE VENTRICULAR LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR LEAD. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD IMPEDANCE DROPPED FROM 540 TO 360 OHMS, BUT HAD BEEN STEADY AT 360 OHMS. LEAD THRESHOLDS ON BOTH THE ATRIAL AND VENTRICULAR LEADS HAD BEEN OVER 2.5V. THE VENTRICULAR LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR LEAD. THE ATRIAL LEAD REMAINS IN USE BECAUSE SENSING FUNCTIONS WERE INTACT AND "PATIENT DOES NOT ATRIALLY PACE OFTEN." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD IMPEDANCE DROPPED FROM 540 TO 360 OHMS, BUT HAD BEEN STEADY AT 360 OHMS. LEAD THRESHOLDS ON BOTH THE ATRIAL AND VENTRICULAR LEADS HAD BEEN OVER 2.5V. THE VENTRICULAR LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR LEAD. THE ATRIAL LEAD REMAINS IN USE BECAUSE SENSING FUNCTIONS WERE INTACT AND "PATIENT DOES NOT ATRIALLY PACE OFTEN." PHYSICIAN ELECTIVELY REPLACED DEVICE AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR AND PATIENT HAD COMPLETE AV (ATRIOVENTRICULAR) BLOCK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER REPORTED BY MOTHER THAT AT EACH DEVICE CHECK, THE BATTERY SHOWED AS DEPLETING. SHE ALSO REPORTED "IT WAS MEDTRONIC'S MALFUNCTIONING LEAD" THAT WAS AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC PUERTO RICO, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR