{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-07",
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          "patient_ethnicity": "",
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          "patient_problems": [
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      "remedial_action": [
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS FURTHER REPORTED THAT PHYSICIAN MADE A MEDICAL JUDGEMENT TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO WHEN REPLACING THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE NO PRODUCT PERFORMANCE ISSUES REPORTED WITH THE IPG."
        },
        {
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          "patient_sequence_number": "1",
          "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "188974978",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK APPROXIMATELY FIVE WEEKS POST IMPLANT A PACING FAILURE, SENSING FAILURE AND DISLODGEMENT WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. X-RAY CONFIRMED THE LEAD HAD BEEN PULLED UP TO THE SUPERIOR VENA CAVA (SVC) DUE TO A LOOSE ANCHORING SLEEVE. THE LEAD WAS REPROGRAMMED AND THEN EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT."
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "05/11/2020"
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}