MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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Information was received from a healthcare provider via a company representative regarding a patient receiving gablofen 500mcg/ml at 125 mcg/day via an implantable pump.The patient¿s medical history included spastic parapalegia.A csf (cerebral spinal fluid) leak/catheter replacement was reported.The patient noticed gradually that fluid was building up in their back and pump pocket.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was physical examination and surgery.The actions and interventions taken to resolve the issue was they replaced the catheter.The patient status was noted as alive, with injury, swollen areas at implant site and pump pocket.The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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Manufacturer Narrative
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Concomitant medical products: product id: 8781.Serial# (b)(4).Implanted: (b)(6) 2022.Explanted: (b)(6) 2022.Product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 26-jan-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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