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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

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 company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for non-malignant pain and chronic low back pain.It was reported the clinician programmer tablet was being used and the rep was in the operating room (or) for a new pump implant.The rep could not get the pump to update.It was noted this was likely related to electromagnetic interference (emi).It was noted the pump was able to be read initially in the box.Now the pump was implanted and no device response.The rep tried replacing the batteries in the communicator and the or lights were off; however, programming could not be completed.They were still in the or and not able to try a new environment at this time and would try in recovery.The event date was (b)(6) 2019.Additional information was received on the same day from the rep who indicated they moved the patient to the post-operative/recovery area and tried utilizing both the 8840 clinician programmer and the tablet and still could not establish telemetry.Additional troubleshooting was performed including obtaining a lead apron and still unable to get successful telemetry with the tablet or the 8840.Again, it was reported the rep was able to successfully interrogate the pump while in the package and this was a brand new pump and catheter implant.Swelling, pump depth, and pump positioning were discussed.Telemetry would be attempted again later.The rep called back and reported they have tried multiple programmers both 8840 and tablet.The lead apron was not successful and still no telemetry and not able to read the pump.It was noted the pump was filled after implant and the pump depth did not seem too deep.The rep would review options with the healthcare provider (hcp) and patient.It was reported they were in an environment that they usually update pumps.Additional information was received on (b)(6) 2019 and the rep met with the patient again today and the pump could still not be interrogated.He also tried using a personal therapy manager (ptm) and no pump found message was continuing to appear.They used both the tablet and 8840 again.Logs from the tablet used for the initial interrogation were requested.No further complications were reported or anticipated.Additional information was received from a healthcare provider (hcp) via a rep on (b)(4) 2019 indicated the patient did not experience any symptoms related to the event.It was noted multiple telemetry attempts were made with multiple clinician programmers and ptm.The cause of the inability to establish telemetry with the new pump was not determined.The event was not resolved, and the patient would need to have the pump replaced under warranty.The patient¿s weight was undetermined.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a company representative (rep) indicated surgery had not been scheduled yet.The rep hoped to see it on the schedule in the next two weeks and would continue to follow up with the customer.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent once analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the company representative.The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Product type: software, product id: a810, serial# unknown, product type: software; product id: 8870, serial# unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed a power on reset of undetermined cause occurred.The evaluation codes have been updated for the pump.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H6: the evaluation code conclusion has been updated for this event.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.

• 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: 8658781
• MDR Text Key: 146665828
• Report Number: 3004209178-2019-10618
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR