BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 9864370 · Received March 23, 2020

    Report

    Report Number
    9612164-2020-01271
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 25, 2020
    Report Date
    April 2, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 3243 H6: FDA CONCLUSION CODE(S): 19 PRODUCT EVENT SUMMARY: THE FULL DELIVERY SYSTEM WAS RETURNED WITH THE DEVICE INTACT IN THE DEVICE CUP. THE DEVICE CUP OF THE DELIVERY SYSTEM WAS DAMAGED. THE DELIVERY SYSTEM INNER SHAFT WAS MECHANICALLY KINKED/BENT AT 1.5 CM FROM THE DISTAL END OF THE RECAPTURE CONE. THERE WAS BLOOD ON THE OUTER SHAFT LOCATED AT THE DISTAL END OF THE STABILITY MEMBER. BLOOD WAS OBSERVED ON THE DEVICE CUP OF THE DELIVERY SYSTEM. VISUAL ANALYSIS OF THE DELIVERY SYSTEM INDICATED DAMAGE DURING USE. THE ANALYST NOTED THE DEVICE CUP WAS DAMAGED. ARTICULATION AND DEPLOYMENT TESTS COULD NOT BE PERFORMED DUE TO THE DAMAGE AS THE DEVICE COULD NOT BE RECAPTURED INTO THE DEVICE CUP FOR TESTING. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MICRA. MODEL#: MC1VR01-DELSYS / EXPIRATION DATE: 28-MAR-2021 / SERIAL#: (B)(4). UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEV RTN TO MFR? YES. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 08-OCT-2019. LABELED FOR SINGLE USE: YES. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION PROCEDURE OF LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THE IPG COULD NOT BE RETRACTED INTO THE DEVICE CUP HOLDER. THE IPG AND DELIVERY SYSTEM WERE PULLED DOWN TO THE INTRODUCER AND REMOVED FROM THE PATIENT. UPON REMOVAL, THE EDGE OF THE DEVICE CUP WAS BENT AND DEFORMED. THE PHYSICIAN SUSPECTS THAT BECAUSE THE ANGLES OF THE IPG AND DEVICE CUP OF THE DELIVERY SYSTEM WERE NOT PARALLEL COMPLETELY AT TIME OF RECAPTURE CAUSED DEFORMATION OF THE DEVICE CUP AND RECAPTURE BECOME IMPOSSIBLE. THE PROCEDURE WAS COMPLETED WITH A NEW IPG AND DELIVERY SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332455 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR