Model Number 8637-40 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Overdose (1988); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.The drug being delivered was baclofen (unknown) with an unknown dose and concentration.The reason for use was not reported.It was reported that the ¿catheter needs repair/replacement.¿ it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was unknown if there were any diagnostics/troubleshooting performed.It was unknown what interventions/actions were taken to resolve the issue.The issue was not resolved at the time of the report and the patient status was listed as ¿alive ¿ no injury.¿ the patient is scheduled for a catheter revision/replacement on (b)(6) 2018.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Continuation of d11: product id 8709sc lot# n144298011 serial# implanted: 2008-(b)(6)explanted: 2018-(b)(6) product type catheter h3 ¿ patient code (b)(4) is no longer applicable for this event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received on 31-oct-2018 from a healthcare professional (hcp) who reported that the patient¿s catheter was replaced on (b)(6)-2018.Before the surgery, the patient was receiving gablofen (2000 mcg/ml at 1300 mcg/day).After the surgery, the pump dose was decreased to 650 mcg/day.In the afternoon, the patient went into overdose with symptoms of somnolence and blood pressure dropping.They reduced the pump to minimum rate (11.9 mcg/day).On (b)(6) 2018 the patient was doing fine, so they programmed the pump to a therapeutic rate of 100 mcg/day.The indication for pump use was cerebral palsy and intractable spasticity.No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the hcp via the rep on 2018-oct-31.The physician¿s nurse reports that the patient had received too much baclofen post-op and was placed in the icu.The pump was placed on minimum flow rate.There were no further complications reported/anticipated.
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Search Alerts/Recalls
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