BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 8283668 · Received January 28, 2019

    Report

    Report Number
    3004209178-2019-01901
    Event Type
    Injury
    Date Received
    January 28, 2019
    Report Date
    February 6, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V203110, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 23-JAN-2013, UDI#: (B)(4). THE PRODUCT IS BEING USED FOR AN OFF-LABEL USE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V203110, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018. PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 23-JAN-2013, UDI#: (B)(4). THE PRODUCT WAS BEING USED FOR AN OFF-LABEL USE. CORRECTION TO PMA: CORRECT PMA IS P840001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE HCP FOUND SOME ABNORMAL IMPEDANCE IN ONE OF THE LEADS WHEN EVALUATING THE DEVICE. THE RIGHT LEAD WAS FOUND TO HAVE A DISCONNECTED CASING, MOST LIKELY RESPONSIBLE FOR THE ABNORMAL IMPEDANCE. THE OPERATIVE REPORT DATED 2018-DEC-21 FROM THE HCP PROVIDED ADDITIONAL INFORMATION: THE PATIENT HAD A LONG-STANDING HISTORY OF URGENCY AND URGE INCONTINENCE. IN 2009 PATIENT UNDERWENT PLACEMENT OF BILATERAL LEADS AND A GENERATOR. RECENTLY, PATIENT PRESENTED AFTER A FALL AND WAS HAVING SOME ABNORMAL STIMULATION. EVALUATION OF THE DEVICE SHOWED SOME ABNORMAL IMPEDANCE CHECKS IN ONE OF THE LEADS AND THE DEVICE WAS NEAR END OF SERVICE. THEREFORE, PATIENT¿S GENERATOR WAS REPLACED WITH A PLAN TO REMOVE ONE OF THE LEADS THAT HAD THE ABNORMAL IMPEDANCES TO LEAVE HER WITH UNILATERAL GENERATOR TO THE OTHER LEAD. INTRA-OPERATIVE FINDINGS: THE RIGHT LEAD WAS FOUND TO HAVE A DISCONNECTED CASING MOST LIKELY RESPONSIBLE FOR THE ABNORMAL IMPEDANCE CHECKS. PATIENT HAD GOOD MOTOR RESPONSE ON THE ELECTRODES ON THE LEFT LEAD AND A NEW GENERATOR WAS PLACED TO THAT LEAD IN A GOOD POSITION. DURING SURGERY, INSPECTION OF THE LEADS SHOWED THAT THE PROTECTIVE CASING OF THE RIGHT LEAD HAD PULLED BACK SO THAT THERE WAS SOME EXPOSED WIRE. THEREFORE, HCP FELT THAT THE WIRE WOULD NEED TO BE REMOVED. THE LEFT LEAD APPEARED TO BE INTACT AND SHOWED EXCELLENT TOE AND BELLOWS RESPONSE AT A LOW THRESHOLD ON ALL ELECTRODES WHEN TESTED WITH THE SCREENER BOX. THE RIGHT LEAD WAS REMOVED COMPLETELY INTACT. WHEN NEW GENERATOR WAS PLACED IMPEDANCE CHECKS WERE WITHIN NORMAL LIMITS. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP): THE TIMEFRAME OF THE PATIENT'S FALL WAS UNKNOWN, AS WAS PATIENT WEIGHT. PATIENT WEIGHT GIVEN WAS (B)(6), HEIGHT:(B)(6). THE BATTERY LIFE WAS OK, NEARING EOS (END OF SERVICE), 9 YEARS. THE RIGHT LEAD HAD DISCONNECTED CASING. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75192 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention