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

Model Number 8637-40

Device Problems Premature End-of-Life Indicator (1480); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/16/2018

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 10 mg/ml of morphine at 0.749 mg/day via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome.It was initially reported on 2018-nov-19 that the patient¿s pump had reached the elective replacement indicator (eri).The patient¿s family indicated that the patient did not experience withdrawal symptoms but did experience an increase in back pain.Regarding any environmental/external/patient factors that may have led or contributed to the issue, it was indicated "he" eri had occurred.It was indicated the healthcare provider interrogated the pump on (b)(6) 2018 and noted the pump should be replaced by 2018-jul-15.The event date was provided as (b)(6) 2018.A pump replacement has been scheduled for (b)(6) 2018.Therefore, the issue had not been resolved at the time of the report.The patient¿s status was provided as alive - no injury.Other medications being taken, patient weight, and medical history were not available.Additional information was received from a healthcare provider via a company representative on (b)(4) 2018.It was noted that a pump refill had been performed with no changes.The elective replacement indicator (eri) was described as having been normal and end of service / end of life occurred on (b)(6) 2018.The pump was not replaced prior to eri and it was indicated as having been unknown why replacement had not taken place prior to reaching the replace by date.It was unknown if the pump was to be returned to the manufacturer and further noted as being dependent on hospital protocol.Regarding if the provided information was confirmed with the physician/account, it was noted that this had been provided to the physician replacing the pump.No further complications were reported or anticipated.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).The rep clarified that they did not see the pump logs.The pump had been interrogated by the healthcare provider.The rep stated that all of the information they had regarding the dates and events was on the telemetry report they submitted which showed the device had been interrogated on (b)(6) 2018 and showed that the elective replacement indicator (eri) occurred on (b)(6) 2018, with a message to replace the pump by (b)(6) 2018.Therefore, the end of service/end of life date was not known.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8112378
• MDR Text Key: 128668455
• Report Number: 3004209178-2018-26431
• Device Sequence Number: 1
• Product Code: LKK
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2012
• 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: 11/28/2018
• Date Device Manufactured: 06/29/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR