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

Model Number 8637-40

Device Problems Filling Problem (1233); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problems Twiddlers Syndrome (2114); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

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 healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient receiving an unknown medication via an implantable pump for non-malignant pain.It was reported the patient's pump had flipped after the patient manipulated the pump.X-rays were performed on (b)(6) 2019 and confirmed the pump had flipped.The patient was scheduled for a pump pocket revision for (b)(6) 2019.The issue was unresolved at the time of the report (b)(6) 2019).The patient's status was provided as alive - no injury.No further complications were reported or anticipated.The patient's medical history included malignant pain.The patient's weight and other medications being taken at the time of the event were not available.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated the "pump had flipped on me twice before, and the first time was in august and they had to do surgery on (b)(6) to fix it and in october it flipped again but that time they were able to manually flip it back with their hands".Patient symptoms were not reported.Additional information was also received from a consumer via a company representative (rep) on 2019-oct-17 indicated the healthcare provider (hcp) suspected the patient was manipulating the pump.The hcp attempted to refill on (b)(6) 2019.The hcp had to manually flip the pump to perform the refill and the refill as successful.The patient also reported the inability to use the personal therapy manager (ptm) when the pump was flipped because it would not communicate with the pump.Actions/interventions taken to resolve the issue included manually flipping the pump back to the correct orientation to perform the refill.The issue was resolved at the time of this report.The patient was receiving intrathecal morphine (concentration and dose unknown), bupivacaine 0.3477 mg/day (concentration unknown), and dilaudid 0.3477 mg/day (concentration unknown) via the pump.Other medications were taking at the time of the event were unable to obtain, not available.Surgical intervention did not occur and was not planned.No further complications were reported or 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 was received from the consumer who reported that their pump had been flipping since implant.The patient can feel the pump flip when she bends over or when she moves around and she knows it flipped twice.The patient also stated that she was having trouble with getting a bolus for 3 weeks.The patient was getting pump not found when she is trying to do a bolus.The patient had a refill on friday and could not get a bolus until this morning because the handset shows pump not found.The patient didn¿t think it was her external equipment as it had been replaced once already.No further complications were reported regarding the event.

• 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: 8927178
• MDR Text Key: 155473807
• Report Number: 3004209178-2019-16269
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR