BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 17246751 · Received July 3, 2023

    Report

    Report Number
    2182207-2023-01288
    Event Type
    Injury
    Date Received
    July 3, 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
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. 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.

    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 WAS URGENTLY ADMITTED WITH AN ABDOMINAL BLISTER RUPTURE AND RE-EROSION OF THE PUMP THROUGH THE ABDOMINAL FOSSA AFTER THE PATIENT HAD A PUMP REPLACEMENT DUE TO A PREVIOUS INFECTION. 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. FOLLOWING THE PUMP REPLACEMENT DUE TO A PREVIOUS INFECTION THE PATIENT HAD BEEN REFERRED FOR HYPERBARIC OXYGEN THERAPY (HBOT). DUE TO THEORETICAL RISKS POSED BY HBOT TO THE IMPLANTED PUMP THEY HAD ELECTED NOT TO PROCEED WITH THE HBOT. TWO MONTHS LATER THE PATIENT HAD DEVELOPED AN ABDOMINAL BLISTER RUPTURE, RE-EROSION OF THE PUMP THROUGH THE ABDOMINAL FOSSA, PERSISTENT DARK DISCOLORATION OF HER ABDOMEN, AND BLISTERS OVERLYING THE PUMP SITE. DURING THE PATIENTS FINAL ADMISSION THEY HAD BEEN WEANED OFF INTRATHECAL BACLOFEN AND TRANSITIONED TO ANTISPASMODIC THERAPY DELIVERED THROUGH A G-TUBE. THE PUMP HAD EVENTUALLY BEEN REMOVED UNEVENTFULLY WITH SUBSEQUENT ABDOMINAL WOUND HEALING. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18767 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H