BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3182891 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10717
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V014846, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V014846, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL (B)(4), FOUND THE HYBRID SOLDER JOINT COLD. BOTH OF THE #4 BOND WIRES WERE BROKEN AND ONE OF THE BOND WIRES WAS MISSING. ONE OF THE #5 BOND WIRES WAS BROKEN NEAR THE HYBRID WELD SITE. BOTH OF THE #6 BOND WIRES WERE BROKEN AND ONE OF THE BOND WIRES WAS MISSING. ONE OF THE #7 BOND WIRES WAS BROKEN AND MISSING. IN ADDITION, AN OPEN ELECTRICAL CONNECTION WAS FOUND AT THE L1 INDUCTOR INDVB SOLDER PAD CONNECTION. ANALYSIS OF THE TWO LEADS, BOTH WERE LOT #V014846, FOUND THE OUTER INSULATION BREACHED ESC. THERE WERE ALSO OPENS ON CIRCUIT 3 ON BOTH LEADS. THE CONDUCTORS WERE ALSO DAMAGED AND BROKEN ON BOTH LEADS DUE TO OVERSTRESS DAMAGE NEAR THE CONNECTOR WELD SITES ANALYSIS OF THE EXTENSIONS, SERIAL (B)(4), FOUND THE BODY CUT THROUGH AND SEGMENTED. THERE WERE NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE TWO UNKNOWN STIMLOC ACCESSORIES FOUND NO ANOMALIES. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ¿EVALUATION FOR SEIZURE FOCUS.¿ IT WAS NOTED THAT THE PATIENT¿S SEIZURES HAD GRADUALLY WORSENED AND THEY WANTED TO LOCALIZE THE SEIZURES TO SEE IF THE PATIENT WAS A CANDIDATE FOR A ¿SURGICAL RESECTION OF THE TREATMENT OF THEIR REFRACTORY EPILEPSY.¿ IT WAS NOTED THAT THEY WERE TAKING OUT THE DBS. IT WAS UNCLEAR WHY THEY WERE REMOVING THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS NOT EFFECTIVE. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THE EVENT AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROGRAMMING DATA APPEARED NORMAL. IMPEDANCE MEASUREMENTS WERE NORMAL. NO OTHER DIAGNOSTIC DATA IS AVAILABLE FROM CLINICAL. THERE WERE NO SYMPTOMS REPORTED WITH THE EVENT "PROGRAMMING-LACK OF EFFICACY." WORSENING SEIZURES WERE ALSO NOT REPORTED BY THE SUBJECT AT THE TIME OF STUDY DISCONTINUATION. THE SUBJECT OPTED TO KEEP DEVICES BUT WITHOUT THERAPY. THE PATIENT THEN HAD THE COMPLETE SYSTEM EXPLANTED SEVERAL MONTHS AFTER EXITING FROM THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283048 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention