MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Kinked (1339); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2017 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 8780, serial# (b)(4), product type: catheter.Product id: 8780, serial# (b)(4), product type: catheter.(b)(4).
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Event Description
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Information was received from a healthcare professional via a manufacturer representative regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for intractable spasticity.It was reported the healthcare professional (hcp) encountered the same issue during intra operative with two patients where the hcp felt the catheter could not advance well/could not advance the catheter and would kink unexpectedly.It was noted that the hcp tried to advance many times.The hcp thought the catheters were kinking more easily than they had seen before it was stated the catheters are not coming back for analysis, but the hcp wanted this reported.It was noted that the hcp cut the tips open on the catheters to check to see if the stylet was truly all the way up, and was stated it was.It was noted that the hcp tried two different 8870 catheters with this patient, and ended up placing an 8731sc for this patient.No symptoms were reported.Event date was noted as (b)(6) 2017.The patient's weight was unknown.No further complications were reported/anticipated.***there was additional information reported that was not relevant to this event and therefore was omitted; see (b)(4) could not advance the catheter.***.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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