BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 17164682 · Received June 20, 2023

    Report

    Report Number
    2182207-2023-01198
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 3, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637-20 LOT# SERIAL# UNKNOWN PRODUCT TYPE PUMP. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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 · 0

    HAS BEEN CORRECTED TO INCLUDE ADDITIONAL INFORMATION PROVIDED IN LITERATURE ARTICLE. UPON FURTHER REVIEW IT HAS BEEN DETERMINED THE AFOREMENTIONED EVENTS ARE SEPARATE ISSUES. SEE REPORT NUMBER 2182207-2023-01288 FOR MOST RECENT 8637-20 PUMP EXPLANT AND PATIENT SYMPTOMS ORIGINALLY CODED ON SYSTEM REPORTED PLI 20. 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

    SCHIAVO S, BRENNA CTA, BHATIA A, MIDDLETON WJ, KATZNELSON R. CLINICAL CONSIDERATIONS FOR IMPLANTED NEUROLOGICAL DEVICES IN PATIENTS UNDERGOING HYPERBARIC OXYGEN THERAPY: A CASE REPORT AND REVIEW OF MANUFACTURER GUIDELINES. INT J ENVIRON RES PUBLIC HEALTH. 2023;20(9):5693. DOI:10.3390/IJERPH20095693 REPORTED EVENTS: ¿ A 27-YEAR-OLD FEMALE EXPERIENCED ABDOMINAL WOUND DEHISCENCE, ABDOMINAL DRAINAGE, SKIN EROSION, AND INFECTION RESULTING IN A PUMP REPLACEMENT. ¿ A 27-YEAR-OLD FEMALE EXPERIENCED AN ABDOMINAL BLISTER RUPTURE, DARK DISCOLORATION OF THEIR ABDOMEN WITH BLISTERS, AND EROSION OF THE PUMP FOLLOWING HYPERBARIC OXYGEN THERAPY (HBOT) RESULTING IN A PUMP EXPLANT.

    Description of Event or Problem · 0

    SCHIAVO S, BRENNA CTA, BHATIA A, MIDDLETON WJ, KATZNELSON R. CLINICAL CONSIDERATIONS FOR IMPLANTED NEUROLOGICAL DEVICES IN PATIENTS UNDERGOING HYPERBARIC OXYGEN THERAPY: A CASE REPORT AND REVIEW OF MANUFACTURER GUIDELINES. INT J ENVIRON RES PUBLIC HEALTH. 2023;20(9):5693. DOI:10.3390/IJERPH20095693 REPORTED EVENTS: A 27-YEAR-OLD FEMALE WITH CEREBRAL PALSY AND SEVERE SPASTICITY DEVELOPED AND INFECTION RESULTING IN A PUMP REPLACEMENT. THE PATIENT HAD A PAST MEDICAL HISTORY OF ABSENCE SEIZURES WITH APNEA, MULTIPLE THORACOLUMBAR SPINE SURGERIES, BILATERAL HIP SURGERIES, A STAGE IV SACRAL PRESSURE ULCER, PERCUTANEOUS FEEDING GASTROSTOMY TUBE, AND A PAST EPISODE OF ASPIRATION PNEUMONIA COMPLICATED BY SEPTIC SHOCK REQUIRING A PROLONGED INTENSIVE CARE UNIT (ICU) ADMISSION. AFTER THE PATIENT'S MOST RECENT PUMP REPLACEMENT, THEY DEVELOPED A SERIES OF INFECTIOUS COMPLICATIONS, REQUIRING MULTIPLE SURGERIES, INCLUDING ABDOMINAL WASHOUT AND EXPOSURE OF THE PUMP EMBEDDED IN A LOWER ABDOMINAL QUADRANT. WHILE IN THE EMERGENCY DEPARTMENT, A DRAINING ABDOMINAL WOUND HAD BEEN IDENTIFIED, AND THE PATIENT HAD BEEN BROUGHT TO THE OPERATING ROOM FOR FURTHER DEBRIDEMENT AND IRRIGATION. DURING SURGERY THEY NOTED FRANK WOUND DEHISCENCE AND EROSION OF THE SKIN OVERLYING THE PUMP. THE PUMP HAD BEEN EXPLANTED AND REPLACED BY A SYNCHROMED II 20 ML PUMP. WOUND SWABS WERE COLLECTED AND LATER SHOWED POSITIVE FOR CORYNEBACTERIUM SPECIES, AND TARGETED ANTIBIOTIC THERAPY HAD BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462894 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H "SEE H10...."