Model Number 1258T/86 |
Device Problem
High impedance (1291)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.
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Event Description
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It was reported that the patient presented for implant of the left ventricular lead.During the procedure the pacing impedance measurement exceeded the upper limit.The procedure was completed with a replacement lead and all parameters were within normal limits.The patient was in good condition following the procedure.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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The reported event of the high lead impedance was not confirmed.As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual examination of the lead found no anomalies.
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Search Alerts/Recalls
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