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

Model Number 8637-40

Device Problems Application Program Problem (2880); Data Problem (3196)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial#: unknown, product type: software.Product id: 8840, serial#: unknown, product type: programmer physician.Other relevant device(s) are: product id: 8870, serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: 8840, serial/lot #: unknown, ubd: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal unknown baclofen 1500 mcg/ml at 1423.6 mcg/day via an implanted pump for intractable spasticity and post spinal cord injury.The event was about programming with the tablet.It was reported the hcp was doing a normal refill with a change in drug concentration [new drug concentration was unknown baclofen 1700 mcg/ml].The hcp had updated the programming [bypassed the bridge bolus per managing hcp¿s request] and attempted to update the pump; however the service code 139 popped up.It was noted she had already tried to update it again, but the same service code popped up again.Troubleshooting included trying a second tablet and she was getting the same error code with the second tablet.It was mentioned during programming with the second tablet, while she was on the bridge bolus tab she was seeing ¿nan¿ in place of where she typically saw the volume.Next the 8840 clinician programmer was used to update the pump.After pump interrogation with the 8840, the hcp was seeing the message ¿pump memory error, drug infusion invalid.¿ the screen was bypassed and the hcp was walked through normal programming.It was further reported while the hcp was programming the ptm, it was not allowing her to change the dose restriction interval (dri) to 1x4 hours so instead she changed it to 5x24 hours and reported that would be okay for the patient.The hcp got to the update pump screen after confirming programming and she was able to update the pump successfully.The logs were checked to see if there were any anomalies and there were none showing in the logs.The hcp was able to update the pump using the 8840 and patient symptoms were not reported.The event date was (b)(6) 2019.It was further reported the company representative (rep) planned to obtain the pump logs.No further complications were reported or anticipated.

Manufacturer Narrative

Continuation of d10: product id 8870 lot# serial# unknown implanted: explanted: product type software product id 8840 lot# serial# unknown implanted: explanted: product type multiple therapy product product id a810 lot# serial# unknown implanted: explanted: product type software product id 8840 lot# serial# unknown implanted: explanted: product type multiple therapy product product id a810 lot# serial# unknown implanted: explanted: product type software h6: corrected rfr for pli30 and pli50.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 8599815
• MDR Text Key: 145487331
• Report Number: 3004209178-2019-09368
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Date Device Manufactured: 07/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 45 YR
• Patient Sex: Male