BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3073116 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06767
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    June 21, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS EXPLANTED HOWEVER IT WAS NOT RETURNED BECAUSE IT WAS ¿SHREDDED DURING REMOVAL.¿ IT WAS FURTHER REPORTED THAT THE REPLACEMENT WENT WELL AND THE PATIENT¿S STIMULATION WAS TURNED BACK ON THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THIS OCCURRED NEAR A REPROGRAMMING SESSION THAT OCCURRED A WEEK PRIOR TO REPORT. THE SAME DAY OR THE DAY AFTER THE PATIENT WENT TO THE BARBER AND WHILE GETTING A HAIRCUT FIRST EXPERIENCED BEING SHOCKED. THE SHOCKING WAS DOWN THE PATIENT'S RIGHT SIDE OF THE BODY, WHICH MEANT THE LEFT LEAD. ON THE WAY HOME IN THE CAR THE PATIENT GOT SHOCKED AGAIN, WHICH LASTED 5 TO 10 SECONDS. NO POSITIONAL CHANGE WAS ASSOCIATED WITH THE SHOCK, AND IT WAS NOTED THE BARBER TRIMMED AWAY FROM THE SCALP WITH THE CLIPPERS. THE DAY AFTER, (B)(6) 2013, THE DEVICE WAS REPROGRAMMED FROM 5V TO 3.5V. THE PATIENT STILL RECEIVED SHOCKING AT 3.5V BUT TO A LESSER DEGREE. THE DEVICE WAS THEN TURNED OFF AND NO SHOCKING HAD OCCURRED WITH IT OFF. THE DAY OF REPORT, AN IMPEDANCE CHECK AT .70 V FOUND NO ABNORMAL IMPEDANCES. NO ABNORMAL IMPEDANCES AT 3.0 V. IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) HAD RUN IMPEDANCES "THE OTHER DAY" AND WAS GETTING OUT OF RANGE RESULTS, WHICH HE HAD RUN AT UP TO 4 V. AN X-RAY WAS ORDERED TO FOR A POSSIBLE FRACTURE IN THE EXTENSION OR LEADS. IT WAS REPORTED THE PATIENT WAS GETTING THERAPEUTIC BENEFIT AT 5 V BUT NOT AT 3.5 V. IT WAS NOTED THE PATIENT FELT "A BIT OF A SHOCK ZINGER" AT AN IMPEDANCE CHECK OF 3 V, REPORTED TO HAVE BEEN MORE "MILD" THAN BEFORE. DURING TROUBLESHOOTING THE DEVICE WAS TURNED BACK ON AT 3.5 V, AND THE PATIENT HAD A "LITTLE BIT OF A CONTRACTION ON THE FACE AND ARM" WHICH THE PATIENT HAD REPORTEDLY NOT HAD AT 5 V. THE DEVICE WAS TURNED DOWN TO 3 V. IT WAS THEN DECIDED THE PATIENT'S HCP DID NOT WANT TO CAUSE PATIENT DISCOMFORT THROUGH PALPATION OF THE DEVICE. THE PATIENT'S HCP OPTED TO JUST DO THE X-RAY. FOLLOW UP INFORMATION RECEIVED THE DAY OF REPORT NOTED THE SHOCKING TO HAVE BEEN THROUGH THE PATIENT'S HAND, ARM, ARMPIT, RIBS AND LEGS ALONG THE WHOLE RIGHT SIDE OF THE BODY. THE DAY THE LEAD WAS PLACED, THERE WAS REPORTED TO HAVE BEEN A SHORT ON A BIPOLAR COMBINATION. ELECTRODES 0 AND 1 HAD A LOW IMPEDANCE READING OF 38 OHMS. IT WAS NOTED THE PATIENT'S TIGHTENING ON THE FACE THAT OCCURRED PREVIOUSLY WAS ON THEIR RIGHT SIDE. THE HCP WENT FORWARD WITH PALPATING AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION WIRE, BUT NOTHING OCCURRED. THE HCP DID NOT PALPATE BEHIND THE EAR, NEAR THE LEAD AND EXTENSION CONNECTION. IT WAS NOTED THE IMPEDANCE READING OF BIPOLAR ELECTRODE PAIR 0 AND 1 HAD AN IMPEDANCE READING OF 2383 OHMS THE DAY OF REPORT, WHICH WERE NORMAL AND NOT LOW OUT OF RANGE AS THEY WERE THE DAY OF LEAD PLACEMENT. ADDITIONAL TROUBLESHOOTING WAS TO OCCUR TO DETERMINE THE CAUSE OF SHOCKING EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE LEAD REPLACEMENT WAS SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT X-RAYS WERE TAKEN AND IT WAS ¿DEEMED THAT NO FRACTURES WERE SEEN.¿ IT WAS NOTED THAT THE CAUSE OF SHOCKING OR JOLTING WAS ¿POSSIBLY DUE TO OPEN OR SHORT CIRCUITS.¿ IT WAS NOTED THAT THE DEVICE ON THE AFFECTED SIDE HAD BEEN TURNED OFF. IT WAS FURTHER NOTED THAT A LEAD REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174668 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention