Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Implant Pain (4561)
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Event Date 11/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference numbers: 1627487-2022-06661; 3006705815-2022-18549.It was reported the patient experienced ineffective therapy and pain at the anchor site.Lead diagnostics indicated invalid impedances.As a result, surgical intervention may be pending to address the issue.The investigation did not determine which lead had invalid impedances.
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Manufacturer Narrative
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D6b-date of explant is unknown.
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Event Description
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Related manufacturer reference number: 3006705815-2023-00631.Additional information received indicated the patient's system was explanted due to an infection.Patient was placed on oral antibiotics to address the issue.
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Manufacturer Narrative
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A patient experienced ineffective therapy and pain at the anchor site was reported to abbott.Lead diagnostics indicated invalid impedances.The investigation did not determine which lead had invalid impedances.It was later determined the system was explanted due to infection.The patient was placed on oral antibiotics to address the issue.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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Search Alerts/Recalls
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