MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Infusion or Flow Problem (2964); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 1999 explanted: (b)(6) 2022, product type catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 20-aug-2001, udi#: (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 provider (hcp) via a company representative regarding a patient receiving dilaudid (54 mg/ml at 12.777 mg/day) and bupivacaine (20 mg/ml at 4.732 mg/day) via an implanted pump.It was reported that during the routine pump replacement procedure, the old pump connector appeared corroded and damaged, so the hcp replaced the catheter connector.It was not able to be determined at the time if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was noted that during the procedure, the hcp attempted to empty the implanted catheter, but was unsuccessful and once the new connector was connected was still unable to withdraw csf (cerebrospinal fluid)/drug.The hcp decided to do a back table prime of the new pump and connected it to the revised catheter.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
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