Model Number DB-1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
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Event Date 04/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-extension upn: (b)(4).Model: nm-3138-55 serial: (b)(4).Batch: 20935214.Product family: dbs-extension upn: (b)(4).Model: nm-3138-55 serial: (b)(4).Batch: 20935214.
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Event Description
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It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.
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Event Description
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It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.Additional information received reported the infection was located around the leads and lead extensions.The patient had tested positive for infection and did well post-operatively.The physician later assessed that the infection was secondary to a sensitivity reaction.
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Manufacturer Narrative
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Correction to the follow-up 1 mdr in block h6.
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Event Description
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It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.Additional information received reported the infection was located around the leads and lead extensions.The patient had tested positive for infection and did well post-operatively.The physician later assessed that the infection was secondary to a sensitivity reaction.
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Search Alerts/Recalls
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