Model Number M00566380 |
Device Problems
Kinked (1339); Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an endovive two-port through the peg jejunal tube was being used for the purpose of administering medication for advanced stage parkinson's disease.The procedure date was on (b)(6) 2016.According to the complainant, there was difficulty administering the duodopa because the jejunal tube had kinked.The problem was resolved at the clinical center by flushing the tubing.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that an endovive two-port through the peg jejunal tube was being used for the purpose of administering medication for advanced stage parkinson¿s disease.The procedure date was on (b)(6) 2016.According to the complainant, there was difficulty administering the "duodopa" because the jejunal tube had kinked.The problem was resolved at the clinical center by flushing the tubing.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information as of june 29, 2017.It was reported that the jejunal tube migrated because all the connectors detached.
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Search Alerts/Recalls
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