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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Pain (1994); Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: th90t01, serial#: unknown, product type: mobile platform.Product id: 8781, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 21-feb-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient with an implantable pump for malignant pain and cancer pain.The pump administered compounded baclofen, dilaudid (1 mg,.75071 mg/day), and bupivacaine (15 mg, 11.26058 mg/day).It was indicated that on (b)(6) 2020 the patient had reported difficulty connecting their personal therapy manger (ptm) and pump in order to activate a bolus.Examination on (b)(6) 2020 revealed mild migration possibly secondary to weight loss in addition to a lumbar site seroma that was also likely secondary to weight loss.It was further reported that during a pump refill on (b)(6) 2020 a reservoir volume discrepancy was noted.The expected reservoir volume (erv) was 2.9 ml and the actual reservoir volume was 16 ml.Probably catheter dislodgement and/or kink was further noted.The device diagnosis was other difficulty connecting ptm and pump, pump migration.The clinical diagnosis was lumbar site seroma.No further diagnostics or intervention occurred, as patient is currently enrolled with hospice.The patient was currently on hospice, so they elected not to perform a procedure to remove the fluid.The patient reported their pain was well controlled on (b)(6) 2020.No further diagnostic and or interventions / action was taken.The benefit did not outweigh the risk of surgical revision.The event was unresolved with no further action planned.Regarding etiology, the relationship of the event to the device or therapy was related and the relationship of the event to the implant procedure was not related.The pump was further reported as having administered dilaudid at a dose rate of 1.1249 mg/day and bupivacaine at a dose rate of 16.87354 mg/day.The patient¿s weight was not measured at baseline.No further patient complications have been reported as a result of this event.

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 received from a healthcare professional (hcp) via a clinical study reported on 2020-(b)(6) the patient denied difficulty activating ptm.On 2020-(b)(6) the patient reported difficulty connecting ptm and pump.The ptm was disabled.On 2020-(b)(6) the patient reported decreased pain relief and increased pain.During the revision, a significant reservoir volume discrepancy was noted indicating a catheter kink.The interrogated reservoir volume (irv) was 5.4ml and the actual aspirate volume was 37ml.The patient experienced no symptoms of withdrawal.The intrathecal rate was decreased 94.3% to essentially suspend therapy.The personal therapy manager (ptm) was disabled.There was no plan for surgical revision as patient was on hospice.The outcome of the event was unresolved at time of study exit/death/study closure.The device diagnosis was catheter kink and the clinical diagnosis was decreased pain relief.Additional information received froma healthcare professional (hcp) via a clinical study reported the patient exited the study on 2020-dec-07.The reason for exit was all enrolled manufacturer products were inactive.No further complications were reported/anticipated.

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 received from a healthcare professional (hcp) via a clinical study, reported on (b)(6) 2021, the patient contacted the clinic requesting, a catheter revision.On (b)(6) 2021, the patient reported, increased pain from their last visit in (b)(6)2020.On (b)(6) 2021, the catheter was spliced, replacing the pump segment.The outcome of the event resolved, without sequelae on (b)(6) 2021.No further complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10733552
• MDR Text Key: 213208589
• Report Number: 3004209178-2020-18647
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 04/18/2021
• Supplement Dates FDA Received: 02/05/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR