BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3467440 · Received November 13, 2013

    Report

    Report Number
    3004209178-2013-20735
    Event Type
    Injury
    Date Received
    November 13, 2013
    Report Date
    October 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37092 LOT# 318250001, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V049849, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V031488, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): A KNOWN GOOD EXTENSION WAS INSERTED INTO THE CONNECTOR PORT OF THE INS AND THE SET SCREWS WERE ABLE TO BE TIGHTENED DOWN. THE SET SCREWS HELD THE EXTENSION IN PLACE WHEN FORCE WAS APPLIED. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY; THE BATTERY WAS NOT IN NEW CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37092, LOT# 318250001, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V049849, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V031488, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEVER HAD A THERAPEUTIC EFFECT. IT WAS REPORTED THAT IMPEDANCES WERE GREATER THAN 4,000 OHMS. IT WAS REPORTED THAT THE PHYSICIAN WAS CURRENTLY ¿EXPLORATING¿ THE RIGHT SIDE, AND IT WAS UNCERTAIN IF THE LEFT SIDE WAS GOING TO BE REPLACED. FURTHER, AN OPEN CIRCUIT AND IMPEDANCE ISSUES WERE REPORTED. ON ELECTRODES C1, C2, 01, 02, 12, 13, AND 23, IMPEDANCES WERE GREATER THAN 4,000 OHMS. IT WAS NOT CLEAR IF THE EXTENSION OR LEAD WAS FRACTURED. IT WAS REPORTED, THE PATIENT WAS NOT GETTING THE ¿EFFECT¿ THAT HE NEEDED, BUT THAT SOME WAS GETTING THROUGH. NO PATIENT FALL OR TRAUMA WAS REPORTED. A LONGEVITY CALCULATION WAS PERFORMED FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH SETTINGS AT 3.2 VOLTS/150 PULSE WIDTH/ 160 HERTZ. C+ 1-3- 737 OHMS. THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 23.49 MONTHS, THE INS BATTERY VOLTAGE WAS 2.82 VOLTS. IT WAS REPORTED THAT THE BOTTOM PONG SETSCREW WAS LOOSE. THE PHYSICIAN TIGHTENED THE SETSCREW, AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS AS A RESULT. IT WAS NOTED THAT A LONGEVITY CALCULATION WAS PERFORMED FOR THE INS. THERAPY IMPEDANCE RE-RAN SHOWED THERAPY 438 OHMS 7.018 MA. IT SHOWED THAT AT 440OHMS FOR THERAPY IMPEDANCE, THE ERI WAS 14.14 MONTHS AND END OF SERVICE (EOS) WAS 17.14 MONTHS. PER THE MANUFACTURER DEVICE REGISTRY, IT WAS NOTED THAT THE PATIENT¿S LEFT SIDED DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON (B)(6) 2013. ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT THE CAUSE OF THE LOOSE SETSCREW WAS UNKNOWN AND THAT THE PATIENT WAS FEELING BETTER. REFER TO MFR REPORT #3004209178-2013-20733.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFERIOR CONTACT OF THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOOSE. THE SCREWS WERE TIGHTENED AND INTRA-OPERATIVE IMPEDANCE WAS CHECKED AND THE SYSTEM WAS IN GOOD WORKING ORDER PER THE OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587411 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention