Model Number 1458Q/86 |
Device Problems
Product Quality Problem (1506); Failure to Sense (1559); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2021 |
Event Type
malfunction
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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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Event Description
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It was reported that the patient presented in clinic for an implant procedure.During the procedure, the physician was unable to retrieve any signal on the pacing system analyzer (psa) through the left ventricular (lv) lead.The connector sleeve did not allow for the entirety of the pin to be exposed.The physician stated either the sleeve was too small or the lead was too big.The lead and connector sleeve were replaced.The patient was stable.
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Manufacturer Narrative
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Additional information: h6.
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Manufacturer Narrative
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A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The product was not returned for additional evaluation.Therefore, the event could not be confirmed, and the cause remains unknown.The reported event will continue to be monitored and trended.
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Search Alerts/Recalls
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