BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 11777157 · Received May 5, 2021

    Report

    Report Number
    3004209178-2021-07220
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    December 12, 2014
    Report Date
    May 14, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994934611
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE DEVICE WAS OVERDISCHARGED. THE ISSUE HAS RESOLVED SINCE.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: EVALUATION DETERMINED THAT STANDARD INVESTIGATION IS NEEDED BECAUSE THE PATIENT REPORTED NOT BEING ABLE TO GET ANY COUPLING BARS WHEN TRYING TO RECHARGE; THIS IS AN ALLEGATION OF A DEVICE FAILURE, WHICH SUGGESTS A POSSIBLE FAILURE OF A DEVICE, LABELING OR PACKAGING TO MEET SPECIFICATIONS. AN ASSESSMENT OF THE SOURCE INFORMATION INDICATES THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED DEVICE FAILURE. ASSESSMENT DETERMINED THAT THERE IS NOT AN EXISTING FORMAL INVESTIGATION FOR THE ISSUE IDENTIFIED IN THIS EVENT. HOWEVER, A NEW FORMAL INVESTIGATION IS NOT POSSIBLE, BECAUSE THERE IS INADEQUATE INFORMATION TO INITIATE FORMAL INVESTIGATION ACTIVITIES; THE REASON THE PATIENT COULD NOT GET ANY COUPLING BARS REMAINS UNCONFIRMED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37612, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37642, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID : 3389S-40, LOT#: V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT#: V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37085-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37651, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED WITH A RECHARGEABLE INS A DAY PRIOR TO THIS REPORT AND THERE WAS A COUPLING PROBLEM. THE PATIENT STATED IT WAS SCARY WHEN THEY WERE WITHOUT THEIR THERAPY DUE TO THE SURGERY. THE PATIENT HAD CHECKED THEIR INS STATUS EVERY DAY SINCE IMPLANT. WHEN THE PATIENT USED THE PATIENT PROGRAMMER TO CHECK THE INS THEY SAW ON AND OKAY AND 4.4 AND 1.8 WITH BARS IN THE MIDDLE. ON THE DAY OF THIS REPORT THE INS WAS ON LOW BATTERY AND THEY WANTED TO KNOW HOW TO RECHARGE. THE RECHARGER WAS PLUGGED IN AND THE PATIENT WAS TRYING TO SITUATE THE HOLSTER SO THE ANTENNA WAS OVER THE INS. THE PATIENT HAD TALKED TO THEIR HEALTHCARE PROFESSIONAL (HCP) ABOUT CHARGING OVER AN UNHEALED WOUND AND THE HCP GAVE THEM APPROVAL TO RECHARGE. AFTER THE PATIENT REPOSITIONED THE ANTENNA AND PRESSED THE GREEN KEY ON THE RECHARGER THE PATIENT WAS NOT ABLE TO GET COUPLING BOXES. THE ANTENNA LOCATE FEATURE WAS USED AND THE PATIENT ONLY GOT A RANGE OF 40-42. THE INS BATTERY WAS FLASHING 1/4 TO 1/2 AT THE TIME OF THIS REPORT. NO SYMPTOMS, INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED THE PATIENT HAD CHRONIC ISSUES WITH GETTING POOR COUPLING WHILE CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE THE PATIENT WAS IMPLANTED. IT WAS NOTED THE PATIENT HAD SOME COGNITIVE DEFICITS AND NEEDED SOME ASSISTANCE. THE REP MENTIONED THE PATIENT HAD SHOWN SOME CONFUSION WITH CHARGING THE INS IN THE PAST WHEN THE PATIENT THROUGH THEY WERE CHARGING THE INS, BUT THE RECHARGER WAS DEPLETED. THE PATIENT HAD DEPLETED THE INS SUCH THAT THERAPY WAS LOST, BUT THEY DIDN'T HAVE ANY OVER-DISCHARGE EVENTS THEY WERE AWARE OF. THE PATIENT WAS NOW LIVING IN A FACILITY WHERE THEY COULD GET MORE CARE AND ASSISTANCE WITH CHARGING THE INS. THE REP HAD ASSISTED WITH RECHARGING IN THE PAST, BUT IT WAS SUGGESTED TO GET A WIRELESS RECHARGER (INS). ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY DID THREE PHYSICIAN MODE RECHARGERS. DURING THE CALL THE REP USED THE ANTENNA LOCATE FEATURE TO CHECK POSITION. AFTER THE REP REPOSITIONED THE ANTENNA, THEY EXITED THE ANTENNA LOCATE FEATURE AND SAW A POWER ON RESET (POR) MESSAGE. THE POR MESSAGE WAS BYPASSED, AND THE REP WAS ABLE TO START CHARGING NORMALLY WITH 8 COUPLING BARS. IT WAS REVIEWED THE REP MUST CHARGE TO ¼ FULL AND CLEAR THE POR MESSAGE WITH THE TABLET BEFORE TURNING THE IMPLANON. THE REP CONFIRMED THEY WERE GOING TO STAY WITH THE PATIENT AND CHARGE TO ¼ FULL AND CLEAR THE POR MESSAGE BEFORE TURNING THE IMPLANT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673591 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR "SEE H10...."| SEE H10