MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Impaired Healing (2378)
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Event Date 10/14/2020 |
Event Type
Injury
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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 gablofen at 350 mcg/day via an implanted pump.The patient¿s medical history included ms (multiple sclerosis).The indication for pump use was intractable spasticity/other spasticity.It was reported that the patient¿s spinal incision was not healing appropriately, and it appeared that the spinal incision was opening up.There were no signs of infection, and the patient was getting benefit from the pump.The patient was taken to surgery on (b)(6) 2021.During the procedure, the spinal portion of the catheter was removed, and a new spinal segment was implanted and attached to the existing pump segment of the catheter.The pump was noted to be intact and functioning.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.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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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 25-feb-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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