Model Number 1458Q/86 |
Device Problems
Difficult to Insert (1316); Product Quality Problem (1506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/25/2020 |
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.
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Event Description
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It was reported that the patient presented to the hospital for a pacemaker lead implant procedure.During the procedure, the physician noted that the pacemaker lead lacked a coating on one third of the distal portion of the lead.The physician attributed this as the reason the lead was unable to advance in the great cardiac vein.The lead was not used to complete the procedure.The patient's condition remained stable.
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Manufacturer Narrative
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The reported event of lack of coating on the distal portion of the lead could not be confirmed.Final analysis found the complete lead was returned in one piece measuring 86.5 cm.Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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