BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3571026 · Received January 13, 2014

    Report

    Report Number
    3007566237-2014-00137
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    March 22, 2013
    Report Date
    December 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    BABU, R., HAZZARD, M. A., HUANG, K. T., UGILIWENEZA, B., PATIL, C. G., BOAKYE, M., LAD, S. P. OUTCOMES OF PERCUTANEOUS AND PADDLE LEAD IMPLANTATION FOR SPINAL CORD STIMULATION: A COMPARATIVE ANALYSIS OF COMPLICATIONS, REOPERATION RATES, AND HEALTH-CARE COSTS. NEUROMODULATION. 2013;16(5):418-426. DOI: 10.1111/NER.12065. SUMMARY: SPINAL CORD STIMULATION (SCS) IS A WELL-ESTABLISHED MODALITY FOR THE TREATMENT OF CHRONIC PAIN, AND CAN UTILIZE PERCUTANEOUS OR PADDLE LEADS. WHILE PERCUTANEOUS LEADS ARE LESS INVASIVE, THEY HAVE BEEN SHOWN TO HAVE HIGHER LEAD MIGRATION RATES. IN THIS STUDY, WE COMPARED THE LONG-TERM OUTCOMES AND HEALTH-CARE COSTS ASSOCIATED WITH PADDLE AND PERCUTANEOUS LEAD IMPLANTATION. WE UTILIZED THE MARKET SCAN DATA BASE TO EXAMINE PATIENTS WHO UNDERWENT PERCUTANEOUS OR PADDLE LEAD SCS SYSTEM IMPLANTATION FROM 2000 TO 2009. OUTCOMES INCLUDING COMPLICATIONS, REOPERATION RATES, AND HEALTH-CARE COSTS WERE EVALUATED IN PROPENSITY SCORE MATCHED COHORTS USING UNIVARIATE AND MULTIVARIATE ANALYSES. THE STUDY COHORT WAS COMPRISED OF 13,774 PATIENTS. AT 90 DAYS FOLLOWING THE INITIAL PROCEDURE, PATIENTS IN THE SCS PADDLE GROUP WERE MORE LIKELY TO DEVELOP A POSTOPERATIVE COMPLICATION THAN PATIENTS RECEIVING PERCUTANEOUS SYSTEMS (3.4% VS. 2.2%, P = 0.0005). TWO-YEAR (6.3% VS. 3.5%, P = 0.0056) AND LONG-TERM (FIVE+ YEARS) (22.9% VS. 8.5%, P <(><<)> 0.0008) REOPERATION RATES WERE SIGNIFICANTLY HIGHER IN THOSE WITH PERCUTANEOUS LEAD SYSTEMS. HOWEVER, LONG-TERM HEALTH-CARE COSTS WERE SIMILAR FOR THOSE RECEIVING PADDLE AND PERCUTANEOUS LEADS ($169,768 VS. $186,139, P = 0.30). WHILE THE IMPLANTATION OF PADDLE LEADS IS ASSOCIATED WITH SLIGHTLY HIGHER INITIAL POSTOPERATIVE COMPLICATIONS, THESE LEADS ARE ASSOCIATED WITH SIGNIFICANTLY LOWER LONG-TERM REOPERATION RATES. NONETHELESS, LONG-TERM HEALTH-CARE COSTS ARE SIMILAR BETWEEN PADDLE AND PERCUTANEOUS LEADS. ADDITIONAL IMPROVEMENTS IN SCS TECHNOLOGIES THAT ADDRESS THE SHORTCOMINGS OF CURRENT SYSTEMS ARE NEEDED TO REDUCE THE RISK OF REOPERATION DUE TO HARDWARE FAILURE. FURTHER STUDY IS REQUIRED TO EVALUATE THE EFFICACY OF NEWER PERCUTANEOUS AND PADDLE SCS SYSTEMS AND EXAMINE THEIR COMPARATIVE OUTCOMES. REPORTED EVENTS: 1. 366 PATIENTS IMPLANTED WITH SPINAL CORD STIMULATION (SCS) PERCUTANEOUS LEAD SYSTEMS UNDERWENT RE-OPERATION IN WHICH ANOTHER PERCUTANEOUS LEAD SYSTEM WAS IMPLANTED. 2. 141 PATIENTS IMPLANTED WITH SCS PERCUTANEOUS LEAD SYSTEMS UNDERWENT RE-OPERATION IN WHICH A PADDLE LEAD SYSTEM WAS IMPLANTED. 3. 53 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS UNDERWENT RE-OPERATION IN WHICH A PERCUTANEOUS LEAD SYSTEM WAS IMPLANTED. 4. 310 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS UNDERWENT RE-OPERATION IN WHICH ANOTHER PADDLE LEAD SYSTEM WAS IMPLANTED. 5. 16 PATIENTS IMPLANTED WITH SCS PERCUTANEOUS LEAD SYSTEMS EXPERIENCED INFECTIONS WITHIN 90 DAYS OF THE IMPLANT PROCEDURE. 6. 8 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS EXPERIENCED INFECTIONS WITHIN 90 DAYS OF THE IMPLANT PROCEDURE. 7. 1183 PATIENTS IMPLANTED WITH SCS PERCUTANEOUS LEAD SYSTEMS HAD AN AVERAGE OF 3 DAYS OF INPATIENT HEALTH CARE IN THE TWO YEARS SINCE IMPLANT. 8. 1183 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS HAD AN AVERAGE OF 4 DAYS OF INPATIENT HEALTH CARE IN THE TWO YEARS SINCE IMPLANT. 9. 236 PATIENTS IMPLANTED WITH SCS PERCUTANEOUS LEAD SYSTEMS HAD AN OVERALL AVERAGE OF 11 DAYS OF INPATIENT HEALTH CARE. 10. 236 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS HAD AN OVERALL AVERAGE OF 13 DAYS OF INPATIENT HEALTH CARE. 11. 8 PATIENTS IMPLANTED WITH SCS PERCUTANEOUS LEAD SYSTEMS EXPERIENCED DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM (DVT/PE) WITHIN 90 DAYS OF THE IMPLANT PROCEDURE. 12. 14 PATIENTS IMPLANTED WITH SCS PADDLE LEAD SYSTEMS EXPERIENCED DVT/PE WITHIN 90 DAYS OF THE IMPLANT PROCEDURE. 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
    25283 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R