BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3140467 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01815
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    July 2, 2012
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CAMERON, A. P., ANGER, J. T., MADISON, R., SAIGAL, C. S., CLEMENS, J. Q. BATTERY EXPLANTATION AFTER SACRAL NEUROMODULATION IN THE MEDICARE POPULATION. NEUROUROLOGY AND URODYNAMICS. 2013;32(3):238-241. DOI: 10.1002/NAU.22294. SUMMARY: THE OBJECTIVE WAS TO DETERMINE SACRAL NEUROMODULATION BATTERY LIFE AND THE PATIENT AND PROVIDER RISK FACTORS FOR EARLY EXPLANTATION IN A POPULATION-BASED SAMPLE. A 5% SAMPLE OF MEDICARE BENEFICIARIES FROM 1997 TO 2007 SERVED AS THE DATA SOURCE. ALL PATIENTS WHO HAD A SACRAL NEUROMODULATIONDEVICE IMPLANTED IN THAT TIME PERIOD WERE INCLUDED. VARIABLES INCLUDED IN A MULTIVARIATE ANALYSIS OF RISK FACTORS FOR REMOVAL INCLUDED GENDER, AGE, RACE, DIAGNOSIS, TYPE OF TEST PHASE, PROVIDER SPECIALTY, AND VOLUME. THE NUMBER OF DEVICE REPROGRAMMING EVENTS WAS ALSO RECORDED IN THIS TIME PERIOD. MEAN FOLLOW-UP WAS 60.5 MONTHS. PATIENTS ON AVERAGE HAD 2.15 REPROGRAMMING EPISODES IN THEIR FIRST YEAR, WITH THAT NUMBER DECREASING OVER SUBSEQUENT YEARS. OUT OF THE 558 BATTERIES IMPLANTED 63 (11.3%) WERE EXPLANTED. OF THE 19 IMPLANTED INDIVIDUALS WHO CARRIED THE DIAGNOSIS OF INTERSTITIAL CYSTITIS (IC), 11 (57.9%) HAD THE BATTERY REMOVED. THIS WAS THE ONLY VARIABLE THAT PREDICTED EARLY REMOVAL, WITH AN ODDS RATIO OF EXPLANTATION OF 10.5 (95% CI: 3.9¿28.4). VERY FEW SACRAL NEUROMODULATION BATTERIES, ONCE IMPLANTED, ARE REMOVED PREMATURELY. PATIENTS WITH IC, HOWEVER, ARE AT VERY HIGH RISK OF REQUIRING PREMATURE BATTERY REMOVAL. REPORTED EVENTS: 1. 3 PATIENTS HAD THEIR IMPLANTABLE NEUROSTIMULATORS (INS) EXPLANTED WITHIN 30 DAYS OF IMPLANT DUETO INFECTION. 2. 6 PATIENTS DIAGNOSED WITH URGENCY INCONTINENCE HAD THEIR INS EXPLANTED AND A NEW ONE IMPLANTED DURING THE SAME PROCEDURE. 3. 1 PATIENT DIAGNOSED WITH INTERSTITIAL CYSTITIS HAD THEIR INS EXPLANTED AND A NEW ONE IMPLANTED DURING THE SAME PROCEDURE. 4. 5 PATIENTS DIAGNOSED WITH NEUROGENIC BLADDER HAD THEIR INS EXPLANTED. THE INS WAS NOT REPLACED. 5. 10 PATIENTS DIAGNOSED WITH INTERSTITIAL CYSTITIS HAD THEIR INS EXPLANTED. THE INS WAS NOT REPLACED. 6. 5 PATIENTS DIAGNOSED WITH RETENTION HAD THEIR INS EXPLANTED. THE INS WAS NOT REPLACED. 7. 26 PATIENTS DIAGNOSED WITH ¿WET¿ OVERACTIVE BLADDER HAD THEIR INS EXPLANTED. THE INS WAS NOT REPLACED. 8. 10 PATIENTS WITH ¿DRY¿ OVERACTIVE BLADDER HAD THEIR INS EXPLANTED. THE INS WAS NOT REPLACED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REVEALED THAT THE 11 PATIENTS WITH INTERSTITIAL CYSTITIS FARED POORLY AND HAD THEIR BATTERY REMOVED EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241270 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention