Model Number G151 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2022 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high-pacing impedance measurements on the non-boston scientific right ventricular (rv) lead.A revision procedure was performed and both products were explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high-pacing impedance measurements on the non-boston scientific right ventricular (rv) lead.A revision procedure was performed and both products were explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem.B2: outcome attributed to adverse event.B5: describe the event or problem field.D6b: explant date.H1: type of reportable event.H6: impact codes.Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Manufacturer Narrative
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Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high-pacing impedance measurements on the non-boston scientific right ventricular (rv) lead.A revision procedure was performed and both products were explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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