BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 18670338 · Received February 8, 2024

    Report

    Report Number
    3004209178-2024-04117
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    August 8, 2022
    Report Date
    February 8, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 37761 LOT# SERIAL (B)(6) : PRODUCT TYPE RECHARGER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL (B)(6) : ANALYSIS OF THE 37761 DESKTOP CHARGER (SERIAL NUMBER (B)(6) REVEALED A BROKEN CONNECTOR PIN. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF REMEDIATION PLAN 411. 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT REPORTED THEY WERE UNABLE TO CHARGE THEIR RECHARGER AND THE ISSUE BEGAN YESTERDAY. PT STATED THE METAL CONNECTOR PIN ON THEIR DESKTOP CHARGER CORD WAS ABOUT TO FALL OFF. PT NOTED THEY PLUGGED THEIR DESKTOP CHARGER TO THE RECHARGER THE NIGHT BEFORE AND THEY WENT TO CHANGE THE SETTING ON THEIR STIMULATOR AND NOTICED THE RECHARGER BATTERY WAS "DEAD". PT NOTED THEY PLUGGED THE DESKTOP CHARGER CORD AGAIN AND THE GREEN LIGHT WAS ON. PT NOTED IT LOOKED LIKE THEY ALMOST STEPPED ON IT OR A CAT GOT A HOLD OF IT (PATIENT SERVICES (PS) UNDERSTOOD THIS AS THE METAL CONNECTOR PIN DAMAGE). AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DESKTOP CHARGER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365944 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male "SEE H10...."