MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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Patient Problems
Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)
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Event Type
Injury
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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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Event Description
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Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that there had been "large volume discrepancies" at the patient's last two refills.The caller was not sure of the volumes, but he was "almost sure there was more drug in the pump that what should be in there." he mentioned a 10 ml discrepancy the last time the patient was seen.The pump was refilled and the patient returned within a week and there was a 10 ml discrepancy.There were no anomalies in the pump logs and a roller study came back fine.The representative reviewed with the hcp that he should check the catheter but the hcp did not believe there was an issue with the catheter and he just wanted the pump replaced.The representative called back later the same day to report that the patient tended to "play around" with the pump which they believe caused it to flip.It was noted the pump was going to be replaced on (b)(6) 2018.It was reviewed that the pump flipping could be related to the volume discrepancies.The event date of the issue was unknown.No further complications were reported.
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Manufacturer Narrative
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(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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It was further reported on (b)(6) 2018 that the patient experienced a complete loss of therapy.
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, (b)(4), implanted: (b)(6) 2017, product type: catheter, product id: 8780, (b)(4), implanted: (b)(6) 2017, product type: catheter.Interrogation of the pump determined it was used to deliver bupivacaine (29.7 mg/ml, 10.979 mg/day).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, (b)(4), implanted: (b)(6) 2017, product type: catheter, product id: 8780, (b)(4), implanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the healthcare professional via manufacturer representative.It was reported that the cause of the volume discrepancy and los of therapy was not determined.The pump and a portion of the pump segment were replaced.The patient's weight was unknown.The device would be returned; a tracking number was unavailable.No further complications were reported/anticipated.
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Manufacturer Narrative
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The pump was returned, and analysis found no anomaly.The catheter was returned, and analysis found damage to the transition tube of the catheter body.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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