BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 10528720 · Received September 14, 2020

    Report

    Report Number
    3004209178-2020-15864
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 5, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PATIENT PROVIDE THEIR WEIGHT INFORMATION AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S FAMILY/FRIEND REPORTED THAT PATIENT HAD HER FIRST OF 10 TREATMENTS FOR RADIATION THERAPY YESTERDAY. PATIENT IS SEEING AN INFORMATIONAL POWER ON RESET (POR) CONTACT CLINICIAN MESSAGE ON HER PATENT PROGRAMMER (PP) AND RECHARGER. THE POR MESSAGE CAN CLEAR FROM THE RECHARGER AND ALLOWS THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) TO RECHARGE (IT'S ABOUT A QUARTER CHARGED NOW) BUT HE CAN SEE THAT THE STIMULATION IS OFF. PATIENT SERVICES (PSS) REVIEWED MEANING OF POR AND GUIDED CALLER THROUGH CLEARING POR WITH THE PP TURNING INS BACK ON. CALLER CONFIRMED THE POR MESSAGE CLEARED AND THE INS IS BACK ON. CALLER CONFIRMED THAT THE INS IS HELPING THE PATIENT'S BACK. CALLER SAID THE PATIENT HAS LET HER INS BATTERY DEPLETE SEVERAL TIMES SINCE SHE'S HAD IT BUT SAID SHE IS ALWAYS ABLE TO CHARGE IT BACK UP. CALLER STATED THAT IT'S RARE IF THE INS IS DEPLETED FOR MORE THAN A DAY. PSS REVIEWED THAT PROGRAMMING SHOULD NOT BE AFFECTED AS LONG AS THE PATIENT HAS ESTABLISHED GOOD CHARGING PRACTICES. CALLER CONFIRMED UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993590 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR