BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6389852 · Received March 8, 2017

    Report

    Report Number
    3004209178-2017-05272
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    January 1, 2017
    Report Date
    June 1, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V475750, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V475750, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT FEELS ELECTRICAL SHOCK SENSATION FROM TOP OF HEAD DOWN FACE, CHEEKS, AND UNDER CHIN AS OF TWO MONTHS PRIOR TO THIS REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP), WHO MET WITH THE PATIENT ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT SHOCKING AND TINGLING IN HEAD, LEFT ARM AND FACE. THE PATIENT REPORTED THAT IT FELT LIKE PULLING IN THE FACE AREA WHEN THE INTERMITTENT SHOCK OCCURS, ALTHOUGH THERE IS NO VISIBLE FACIAL PULL. IT WAS REPORTED THAT THE SHOCKING CANNOT BE PINPOINTED TO A SPECIFIC POSITION OR POSTURE. IT WAS NOTED THAT THE PATIENT HAD SOME FALLS RECENTLY, BUT NONE THAT COULD BE ASSOCIATED TO THE SHOCKING PROBLEM SPECIFICALLY. LOW IMPEDANCE OF 102 OHMS WAS MEASURED ON CONTACT (B)(6) OF THE RIGHT LEAD. THERE WERE NO LOW IMPEDANCES MEASURED ON THE PATIENT¿S TRIP TO THE HCP¿S OFFICE ON (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED. IMPEDANCES ON (B)(6) 2017 LEFT C & 0: 2441 OHMS C & 1: 900 OHMS C & 2: 810 OHMS C & 3: 1294 OHMS 0 & 1: 2400 OHMS 0 & 2: 2744 OHMS 0 & 3: 3376 OHMS 1 & 2: 1145 OHMS 1 & 3: 1816 OHMS 2 & 3: 1441 OHMS RIGHT C & 8: 853 OHMS C & 9: 857 OHMS C & 10: 771 OHMS C & 11: 744 OHMS 8 & 9: 1211 OHMS 8 & 10: 1294 OHMS 8 & 11: 1085 OHMS 9 & 10: 1126 OHMS 9 & 11: 1265 OHMS 10 & 11: 1047 OHMS IMPEDANCES ON (B)(6) 2017 C & 0: 1987 OHMS C & 1: 890 OHMS C & 2: 819 OHMS C & 3: 1517 OHMS 0 & 1: 1933 OHMS 0 & 2: 2241 OHMS 0 & 3: 3083 OHMS 1 & 2: 1141 OHMS 1 & 3: 1922 OHMS 2 & 3: 1636 OHMS RIGHT C & 8: 545 OHMS C & 9: 872 OHMS C & 10: 795 OHMS C & 11: 537 OHMS 8 & 9: 988 OHMS 8 & 10: 921 OHMS 8 & 11: 102 OHMS 9 & 10: 1141 OHMS 9 & 11: 988 OHMS 10 & 11: 910 OHMS.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE CAUSE OF THE SHOCKING SENSATION WAS STILL UNKNOWN. THE LEAD WAS REPLACED ON (B)(6) 2017 AND THE INS WOULD BE ACTIVATED ON (B)(6) 2017. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE PATIENT WAS SCHEDULED FOR A REPLACEMENT/REVISION SURGERY TOMORROW ((B)(6) 2017). THE REP REPORTED THAT WHEN PRESSING ON THE LEAD/EXTENSION SITE, THE PATIENT FELT SHOCKING/STIM SENSATION. THE REP REPORTED THAT THE EXTENSION WAS REPLACED WITHOUT RESOLVING THE ISSUE. THE REP REPORTED THAT TOMORROW THE PATIENT'S HEALTHCARE PROVIDER (HCP) WILL REPLACE THE SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170342 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention