MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780; serial#: (b)(4); implanted: (b)(6) 2022; explanted: (b)(6) 2022; product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-oct-2023, 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving morphine (9.6 mg/ml at 1.5 mg/day) via an implantable pump for unknown indications for use.It was reported that during an unrelated ct, the imaging identified that the catheter had migrated out of the intrathecal space.It was unknown if there were any factors that may have led or contributed to the issue.An exploratory surgery was done on (b)(6) 2022 and found the catheter coiled up in the back near the anchor.A 8782 catheter was used to replace the migrated portion.The issue was resolved at the time of report.The patient's weight was asked and will not be made available.The patient's medical history included cancer.The patient's status at the time of report was alive - no injury.
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Search Alerts/Recalls
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