Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Sepsis (2067)
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Event Date 01/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If the product is returned, it will not be analyzed as the complaint of infection can not be confirmed via laboratory testing.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 3 of 4.Reference mfr report numbers : 3006705815-2016-00057, 1627487-2016-00665, 1627487-2016-00797.Device 3 and 4 were added to address the leads.Note: as it is unknown which devices were explanted, all are being reported.It was reported one of the patient's system was explanted.The patient is currently being treated with iv antibiotics.
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Event Description
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Device 3 of 4.Reference report numbers - 3006705815-2016-00057, 1627487-2016-00665, 1627487-2016-00797.It was determined only one ipg was explanted on (b)(6) 2016 (device 1).Both of the leads were explanted (devices 3 & 4).Device 2 remains implanted.
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Search Alerts/Recalls
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