MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Human-Device Interface Problem (2949)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal baclofen 2000 mcg/ml at 216.1 mcg/day via an implantable pump.It was reported that the patient showed overdose symptoms.The physician operated emergency procedures on the patient.Additionally, the patient wanted to stop the pump.The device manufacturer technical services department provided the manufacturer representative with a pump stop code.It was further reported that the patient responded positively to the retrieval of cerebrospinal fluid (csf) from the catheter access port (cap) operated by the physician.For this reason, the physician decided not to stop the pump, but rather give a priming bolus and continue to give the patient the intrathecal baclofen therapy.It seemed that during the cap procedure, some blood was retrieved as well.However, the physician suspected that the blood was coming from the surrounding tissue and not from the csf, as the healthcare professional (hcp) had to do multiple punctures before getting into the cap.The patient was not reported to having been involved in an accident or trauma.It was noted that on (b)(6) 2020 the patient had a pump refill, suggesting that the overdose could be due to a pocket refill.However, this could not be confirmed so far as the pump reservoir had not been emptied yet.During the interrogation of the pump, no error codes or alarms were reported by the physician programmer.The elective replacement indicator (eri) was calculated to occur in 6 months.Information regarding the pump implant date was not available.It was unknown if any environmental, external or patient factors might have led or contributed to the event.It was unknown if any [additional] diagnostics/troubleshooting were performed.It was unknown if any [additional] actions/interventions were taken.Surgical intervention did not occur and was not planned.The issue was resolved.The patient's status was alive - no injury.Information regarding the patient¿s age, weight, medical history, and other medications was unavailable.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Event Description

Additional information was received from a foreign manufacturer representative on 2020-jul-28.It was reported that the cause of the difficulty accessing the cap and requiring multiple punctures was unknown.The patient's overdose symptoms occurred the next morning after the refill.The physician determined that the symptoms were unlikely to be caused by a pocket fill after physically inspecting the pocket.No imaging was used to confirm the needle position.It was unknown if the fluid removed from the pump had the expected appearance.It was confirmed that the volume injected into the pump was not excessively different from the expected volume.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Event Description

Additional information was received in response to a request for follow-up.The additional information indicated that the specific o verdose symptoms that the patient experienced after the refill was a drop in blood pressure.It was clarified that the patient did not show any overdose symptom at the time of retrieving the csf sample procedure.It was further described that the csf sample retrieved during the reported emergency procedure performed was sent to a laboratory to determine if there was any infection.It was also confirmed that there was no change in programming made [other than the reservoir volume] at the refill prior to the overdose event.However, the cause of the overdose symptoms was not determined and the patient had recovered.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10286535
• MDR Text Key: 199221311
• Report Number: 3004209178-2020-12351
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other