MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Obstruction of Flow (2423); Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving clonidine (unknown dose and concentration), compounded baclofen (unknown dose and concentration), dilaudid (hydromorphone) (unknown dose and concentration), and bupivacaine (unknown dose and concentration) via an implantable pump for unknown indications for use.
It was reported on (b)(6) 2021 the patient presented to the operating room for a pump replacement secondary to normal end of battery life and an occlusion at the proximal segment of the catheter was observed.
The implanting physician was unable to insert the spinal segment in the desired space.
The pump segment was coiled in the pump pocket and the pump was programmed to minimal rate.
The plan was to refer to a neurosurgeon.
On (b)(6) 2021 the existing catheter was removed, and a new catheter was attempted to be implanted but the spinal segment could not be threaded up to the desired level.
Therapy was suspended and the pump was programmed to minimal rate.
The outcome was noted as ongoing.
The device diagnosis was catheter occlusion.
The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.
The event date was (b)(6) 2021.
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Manufacturer Narrative
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Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter.
Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 20-nov-2016, udi#: (b)(4).
If information is provided in the future, a supplemental report will be issued.
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