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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

Patient Problems Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving gablofen (200 mcg/ml at 1000 mcg/day) via an implantable infusion pump.The indication for use was intractable spasticity.It was reported that a refill was performed on (b)(6) 2019 and the elective replacement indicator (eri) was shown to be 33 months but on (b)(6) 2019 and the hcp used the tablet for the first time with the patient and in the logs it noted that eri had occurred on (b)(6) 2019.The caller stated the patient and their caregiver had not heard any alarms.No symptoms were reported.No further complications have been reported as a result of this event.

Manufacturer Narrative

Additional review of the provided information indicated that this section needed to be updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the pump was replaced on (b)(6) 2019 and would be returned.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ the patient¿s weight and medical history were asked but unknown.It was also indicated the patient was receiving intrathecal lioresal (concentration and dose unknown).No further complications have been reported as a result of this event.

Manufacturer Narrative

Analysis of the pump found ¿pump - voltage related eri or eos - undetermined cause¿ and ¿pump ¿ low battery reset ¿ undetermined cause¿.If information is provided in the future, a supplemental report will be issued.

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 healthcare provider (hcp) indicated that while trying to update the pump the service code 139 was displayed.The caller was advised to re-interrogate and he received the message 92 for end of service (eos).It was noted that the patient was in distress and experiencing withdrawal so no additional troubleshooting was able to be performed during the call.The expected eos was 2019-nov-23 and the hcp was attempting to titrate the patient down off medication but it had not gone well.No further complications have been reported as a result of this 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: 9071371
• MDR Text Key: 162275074
• Report Number: 3004209178-2019-17717
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR