BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3190343 · Received June 26, 2013

    Report

    Report Number
    3007566237-2013-02112
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. CONCOMITANT : PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN. PRODUCT TYPE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ENGLE, M. P., VINH, B. P., HARUN, N., KOYYALAGUNTA, D. INFECTIOUS COMPLICATIONS RELATED TO INTRATHECAL DRUG DELIVERY SYSTEM AND SPINAL CORD STIMULATOR SYSTEM IMPLANTATIONS AT A COMPREHENSIVE CANCER PAIN CENTER. PAIN PHYSICIAN. 2013;16(3):251-257. SUMMARY: THE OBJECTIVE WAS TO DETERMINE IF CANCER PAIN PATIENTS HAVE A HIGHER INCIDENCE OF INFECTIOUS COMPLICATIONS FOLLOWING IMPLANTATION OF IDDOR SCS SYSTEMS THAN NON-CANCER PAIN PATIENTS. FOLLOWING LOCAL INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL, WE COLLECTED DATA ON INFECTIOUS COMPLICATIONS FOR IDD AND SCS SYSTEMS IMPLANTED AT MD ANDERSON CANCER CENTER FOR THE TREATMENT OF CANCER AND CHRONIC PAIN. THE EXAMINED IMPLANTS WERE PERFORMED FROM JULY 15, 2006, TO JULY 14, 2009. IN ADDITION, WE OBTAINED DATA REGARDING PATIENT COMORBIDITIES AND PERIOPERATIVE RISK FACTORS TO ASSESS THEIR IMPACT ON INFECTIOUS COMPLICATIONS. ONE HUNDRED FORTY-TWO DEVICES WERE IMPLANTED IN131 PATIENTS DURING THE EXAMINED PERIOD. EIGHTY-THREE OF THE DEVICES WERE IDD SYSTEMS AND 59 WERE SCS SYSTEMS. EIGHTY PERCENT OF THE PATIENTS HAD A DIAGNOSIS OF CANCER. FOUR INFECTIOUS COMPLICATIONS WERE NOTED WITH AN OVERALL INFECTIOUS RISK OF 2.8%. THE INFECTION RATE WAS 2.4% FOR IDD SYSTEMS VERSUS 3.4% FOR SCS SYSTEMS (P = 1). ALL INFECTIONS WERE AT THE IMPLANTABLE PULSE GENERATOR (IPG) OR PUMP POCKET SITE. THE RATE OF INFECTION WAS 2.7% FOR CANCER PATIENTS AND 3.3% FOR NON-CANCER PATIENTS (P = 1). NEITHER THE PERIOPERATIVE ADMINISTRATION OF PROPHYLACTIC ANTIBIOTICS (P = 0.4) NOR THE NATIONAL NOSOCOMIAL INFECTION SURVEILLANCE (NNIS) RISK LEVEL FOR INDIVIDUAL PATIENTS (P = 0.15) WERE STATISTICALLY ASSOCIATED WITH INFECTIOUS COMPLICATION. THE MEAN SURGICAL TIME WAS LONGER FOR CASES WITH INFECTION AT 215 ± 93 MINUTES VERSUS 132 ± 52 MINUTES FOR THOSE WITHOUT INFECTION WHICH WAS STATISTICALLY SIGNIFICANT (P = 0.02). THE MAJOR LIMITATION OF THIS STUDY IS THAT IT WAS A RETROSPECTIVE ANALYSIS. AN ADDITIONAL LIMITATION IS THAT 51(38.9%) OF OUR PATIENTS EITHER DIED OR WERE LOST TO FOLLOW-UP DURING THE YEAR FOLLOWING IMPLANTATION WHICH MAY HAVE LED TO AN UNDERESTIMATION OF OUR INFECTION RATES. THE EXPERIENCE OF THIS TERTIARY CANCER PAIN CENTER DEMONSTRATES THAT INFECTIOUS COMPLICATIONS FOLLOWING IMPLANTATION OF IDD AND SCS SYSTEMS ARE RELATIVELY RARE EVENTS IN CANCER PATIENTS. CONTRARY TO OUR INITIAL HYPOTHESIS, NO DIFFERENCE WAS FOUND IN THE INFECTION RATE BETWEEN CANCER AND NON-CANCER PATIENTS. THE MAIN FACTOR ASSOCIATED WITH INCREASED RISK OF INFECTIOUS COMPLICATIONS WAS INCREASED SURGICAL TIME, INDICATING A NEED TO MINIMIZE PATIENT TIME IN THE OPERATING ROOM. THE LOW INFECTIOUS COMPLICATION RATE SEEN IN THIS SERIES COMPARED TO PREVIOUS REPORTS IN NON-CANCER PATIENTS IS LIKELY MULTIFACTORIAL IN NATURE. REPORTED EVENTS: OF THE 131 PATIENTS INCLUDED IN THE STUDY, 33 DIED DURING THE YEAR. EIGHT PATIENTS HAD TWO OR MORE SURGICAL PROCEDURES DUE TO IMPLANTATION OF BOTH AN INTRATHECAL DRUG DELIVERY (IDD) DEVICE AND A SPINAL CORD STIMULATION (SCS) DEVICE; A REVISION OF THE ORIGINAL IMPLANTATION; STAGED IMPLANTATIONS OF MULTIPLE SCS SYSTEMS; OR EXPLANTATION WITH SUBSEQUENT REIMPLANTATION OF A SCS SYSTEM. IT IS NOT KNOWN WHICH TYPE OF DEVICE HAD WHICH ISSUES, NOR IS IT CLEAR WHICH PATIENTS EXPERIENCED WHICH ISSUES. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291157 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention