MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
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 03/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8731sc; serial#: (b)(4); implanted: (b)(6) 2008; explanted: (b)(6) 2022; product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 09-may-2009, 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 saline via an implanted pump.It was reported that the patient was taken to the or (operating room) for the catheter to be pulled down from c2 to t10.Upon doing a bolus to flush the catheter, it would not drip.The hcp then opened the pump pocket, and the catheter broke when he moved it.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The catheter was replaced.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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Search Alerts/Recalls
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