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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)

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

Event Date 09/13/2018

Event Type  Injury  

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 the patient was receiving intrathecal lioresal 2000 mcg/ml at 500 mcg/day via an implanted pump.It was reported the event/difficulty occurred on (b)(6) 2018 during normal use.A motor stall and the elective replacement indicator (eri) occurred and it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.Actions/interventions taken to resolve the issue included replacement of the pump and the issue was resolved at the time of this report.Other medications the patient was taking at the time of the event was unable to obtain, not available.The patient¿s weight and medical history were unknown, asked and would not be made available (legal/confidential reason).The patient¿s status at the time of this report was ¿alive- no injury.¿ no further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Information was received from a consumer, a healthcare professional (hcp), and a manufacturer representative (rep) regarding a patient receiving gablofen 2000mcg/ml for a total dose of 500.5mcg/day via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported the patient alleged their pump was beeping or alarming.Patient stated they were hearing a single beep once and hour since (b)(6) 2018 (patient stated 3 days ago).The patient stated their alarm date is not until (b)(6) 2018 and their last refill was (b)(6) 2018.The patient stated there was no falls or traumas.The alarm was consistent with synchromed alarms.The patient was to follow up with their hcp.Additional information received from a rep indicated that they heard from the hcp and there was a premature elective replacement indicator (eri) that occurred and the patient heard their pump "beeping every hour." per the event logs, eri occurred on (b)(6) 2018.The rep did not know if there was any other anomalies per the logs.The rep stated the patient had their pump filled on (b)(6) 2018 and the eri was 30 months at that time.No further troubleshooting could be done due to lack of access to hcp or patient.The rep will confer with hcp and patient.Additional information received from hcp indicated eri occurred on (b)(6) 2018 and there were no other events in the logs.It was reviewed what the patient dose was programmed to and silencing the alarm.It was reviewed that since eri is premature, to replace the pump as soon as medically appropriate, since eos timeline could be shortened with a pump that has premature eri.It was reviewed to send pump back for analysis.The event date was (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

The pump was returned, and analysis found motor feedthru anomaly and shorting across the insulator.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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7899504
• MDR Text Key: 123142372
• Report Number: 3004209178-2018-21295
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Date Manufacturer Received: 01/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR