BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7606886 · Received June 15, 2018

    Report

    Report Number
    3007566237-2018-01799
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    April 3, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8637, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:; PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:; PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. BARTEK J, JR., SKYRMAN S, NEKLUDOV M, MATHIESEN T, LIND F, SCHECHTMANN G. HYPERBARIC OXYGEN THERAPY AS ADJUVANT TREATMENT FOR HARDWARE-RELATED INFECTIONS IN NEUROMODULATION. STEREOTACT FUNCT NEUROSURG. 2018. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)_LIT.PDF].

    Description of Event or Problem · 1

    SUMMARY: IN NEUROMODULATION THERAPIES, HARDWARE-RELATED INFECTIONS ARE A MAJOR CHALLENGE OFTEN LEADING TO HARDWARE REMOVAL. A (B)(6)-YEAR-OLD MALE PATIENT WITH A DIAGNOSIS OF CEREBRAL PALSY EXPERIENCED A BATTERY POCKET INFECTION (SUPERFICIAL SURGICAL SITE INFECTION) 10 DAYS AFTER EXCHANGE OF THEIR INTRATHECAL BACLOFEN PUMP. THE PUMP WAS IMPLANTED IN THE SUBCUTANEOUS TISSUE OF THE ABDOMEN. MATERIAL WAS COLLECTED ASEPTICALLY FOR AEROBIC AND ANAEROBIC BACTERIAL CULTURES. A WOUND CULTURE REVEALED THE INFECTION TO BE (B)(6). THERE WAS NO SURGICAL SITE REVISION. THERE WAS NO IMPLANT EXPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ADJUVANT HYPERBARIC OXYGEN THERAPY (HBOT). HYPERBARIC TREATMENT WAS ADMINISTERED AT 2.0 TO 2.8 BARS. THE PATIENT RECEIVED CLINDAMYCIN, DICLOXACILLIN, OR FLUCLOXACILLIN. THE TIME TO INFECTION RESOLUTION WAS 12 WEEKS. LONG TERM INFECTION CONTROL WAS ACHIEVED. THIS WAS CONSIDERED A POST-OPERATIVE HARDWARE-RELATED INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. A (B)(6)-YEAR-OLD MALE PATIENT WITH A DIAGNOSIS OF CEREBRAL PALSY EXPERIENCED A LOWER BACK INCISION INFECTION (SUPERFICIAL INCISIONAL SURGICAL SITE INFECTION) 13 DAYS AFTER REVISION OF THE CATHETER AND EXCHANGE OF THE INTRATHECAL PUMP (BACLOFEN). THE PUMP WAS IMPLANTED IN THE SUBCUTANEOUS TISSUE OF THE ABDOMEN. NO WOUND CULTURE WAS TAKEN. THERE WAS NO SURGICAL SITE REVISION. THERE WAS NO IMPLANT EXPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ADJUVANT HBOT. HYPERBARIC TREATMENT WAS ADMINISTERED AT 2.0 TO 2.8 BARS. THE PATIENT RECEIVED CLINDAMYCIN, DICLOXACILLIN, OR FLUCLOXACILLIN. THE TIME TO INFECTION RESOLUTION WAS 10 WEEKS. LONG TERM INFECTION CONTROL WAS ACHIEVED. THIS WAS CONSIDERED A POST-OPERATIVE HARDWARE-RELATED INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A DIAGNOSIS OF NEUROPATHIC PAIN EXPERIENCED AN INTRATHECAL PUMP POCKET INFECTION (SUPERFICIAL SURGICAL SITE INFECTION) 14 DAYS AFTER THE IMPLANT OF THE INTRATHECAL PUMP (BACLOFEN). MATERIAL WAS COLLECTED ASEPTICALLY FOR AEROBIC AND ANAEROBIC BACTERIAL CULTURES. THE WOUND CULTURE WAS (B)(6). IT WAS STATED 1 SURGICAL SITE REVISION WAS PERFORMED, BUT THERE WAS NO IMPLANT EXPLANTATION. A WOUND DEBRIDEMENT OR CRUST REMOVAL WAS PERFORMED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ADJUVANT HYPERBARIC OXYGEN THERAPY (HBOT). HYPERBARIC TREATMENT WAS ADMINISTERED AT 2.0 TO 2.8 BARS. THE PATIENT RECEIVED CLINDAMYCIN, DICLOXACILLIN, OR FLUCLOXACILLIN. THE TIME TO INFECTION RESOLUTION WAS 12 WEEKS. LONG TERM INFECTION CONTROL WAS ACHIEVED. THIS WAS CONSIDERED A POST-OPERATIVE HARDWARE-RELATED INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A DIAGNOSIS OF NEUROPATHIC PAIN EXPERIENCED AN INTRATHECAL PUMP POCKET INFECTION (DEEP INCISIONAL SURGICAL SITE INFECTION) 30 DAYS AFTER THE IMPLANT OF THE INTRATHECAL PUMP (CLONIDINE). A WOUND CULTURE WAS NOT TAKEN. THERE WAS NO SURGICAL SITE REVISION. THERE WAS NO IMPLANT EXPLANTATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ADJUVANT HYPERBARIC OXYGEN THERAPY (HBOT). HYPERBARIC TREATMENT WAS ADMINISTERED AT 2.0 TO 2.8 BARS. THE PATIENT RECEIVED CLINDAMYCIN, DICLOXACILLIN, OR FLUCLOXACILLIN. THE TIME TO INFECTION RESOLUTION WAS 10 WEEKS. LONG TERM INFECTION CONTROL WAS ACHIEVED. THIS WAS CONSIDERED A POST-OPERATIVE HARDWARE-RELATED INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. A (B)(6)-YEAR-OLD MALE PATIENT WITH A DIAGNOSIS OF CEREBRAL PALSY EXPERIENCED A CATHETER REVISION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. A (B)(6)-YEAR-OLD MALE PATIENT WITH A DIAGNOSIS OF CEREBRAL PALSY EXPERIENCED AN INTRATHECAL PUMP MALFUNCTION CAUSED BY HBOT AT 2.8 BARS. THERE WAS PUMP REMOVAL AFTER THE PREVIOUSLY MENTIONED INFECTION RESOLUTION. IT WAS ALSO STATED THIS REMOVAL OCCURRED 2 MONTHS AFTER THE END OF HBOT. THE MALFUNCTION WAS CAUSED BY BAROTRAUMA RESULTING IN AN INADEQUATE REFILLING CAPACITY OF THE PUMP (14 ML INSTEAD OF THE NORMAL 20 ML). IT WAS NOT POSSIBLE TO FILL THE DRUG RESERVOIR UP TO MAXIMAL CAPACITY (20 ML). THE HEALTHCARE PROVIDER (HCP) SUSPECTED THAT THE AIR-FILLED RESERVOIR HAD IMPLODED OR SHRUNK AT THE 2.8 BAR TREATMENT PRESSURE LEVEL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448713 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention