MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTBA1D1 |
Device Problems
High impedance (1291); Misconnection (1399)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 5076-45, lead, implanted: (b)(6) 2002, 1559-65, lead, implanted: (b)(6) 2001.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that high, out-of-range defibrillation coil impedance was noted on the right ventricular (rv) lead post-generator replacement.Initially, all electrical measurements were within the normal range.The physician determined that the rv coil connector pin was probably not well-seated in the cardiac resynchronization therapy defibrillator (crt-d) header.The patient was scheduled for a procedure to reinsert the lead into the device header.Inconsistent impedance was pre-operatively noted.Both normal and out-of-range impedance was observed.It was ultimately decided to leave the lead as is and disable defibrillation therapy.The device and lead remain in use.No patient complications have been reported as a result of this event.
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