MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Infusion or Flow Problem (2964)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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Event Type
malfunction
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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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Additional information was received from the manufacturer¿s representative (rep) on 2018-jun-20.It was reported that it was unknown if further diagnostics/troubleshooting was performed, it was unknown what actions/interventions were taken to resolve the issues, it was unknown if the issue had been resolved, and the patient¿s weight was unknown.It was reported that serous fluid was not confirmed.The cause of the volume discrepancy and inability to aspirate was not determined.The current status of the device was ¿in use.¿ the information was confirmed with the physician.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (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 a consumer via a company representative regarding a patient who was receiving hydromorphone with concentration 18 mg/ml at a dose rate of 10.4 mg/day and bupivacaine with concentration 11 mg/ml at an unknown dose rate via an implantable pump for non-malignant pain and chronic low back pain.It was reported that at the last pump refill in (b)(6) 2018 (month and year specified only) a reservoir volume discrepancy occurred; 16 ml was the actual residual volume and the expected residual volume was 2 ml.There was no withdrawal symptom, but the patient experienced increased pain.The date of the increased pain was unknown.Regarding the reservoir volume discrepancy, it was indicated that the physician thought the practitioner maybe aspirated serous fluid instead of drug via the reservoir and that the patient would have had withdrawals without the intrathecal dose.The company representative did not think the patient had any other prescribed medications to take if they were not receiving the intrathecal medications.The company representative noted there was nothing reported for a possible pocket fill and no overdose symptom that the company representative was aware of.The company representative had utilized a clinician programmer on (b)(6) 2018.It was further reported that the healthcare provider (hcp) was unable to aspirate the catheter access port (cap), not measurable aspirate per the reporter, for a catheter dye study to confirm catheter patency.They tried utilizing 3 cc and 10 cc syringes and were still not successful with the aspiration, so a roller study was performed.The roller study was successful.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This field was corrected to include adverse event and product problem (previously product problem only.If information is provided in the future, a supplemental report will be issued.
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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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Manufacturer Narrative
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(b)(4) no longer apply.(b)(4) now applies.(b)(4).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 manufacturer¿s representative (rep) on 2018-jul-11.It was reported that there were oth er refills where the volume was off and it appears to be increasing.She stated on 2018-mar-22 they got back about 3 ml's, on 2018-apr-18 about 5 ml's, on 2018-jun-13 about 15.8 ml's and at the last refill about 15 ml's.She mentioned in most cases they were expecting about 2 ml's so the volumes she mentioned were the total, not the amount off.She also mentioned the rotor study done on 2018-jun-18 as well and said the pump was turning as expected.The rep did not know if they tried to aspirate from the catheter.The caller stated the patient hasn't been getting pain relief despite being on very high doses of medication.She mentioned 10.4 mg/day of hydromorphone and 6.4 mg/day of bupivacaine.There were no further complications reported/anticipated.
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Search Alerts/Recalls
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