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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 08/08/2019

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 healthcare provider (hcp) via a company representative regarding a patient who was receiving baclofen with concentration 2000.0 mcg/ml at a dose rate of 1050.6 mcg/day via an implantable pump for head/brain injury and intractable spasticity.It was reported that a pump alarm occurred due to an unexpected elective replacement indicator (eri).It was noted that at the last refill on (b)(6) 2019 everything went fine and on the report, it stated the patient had 24 months until eri would occur.However, today ((b)(6) 2019) when the patient came in for a refill, the report was indicating that eri occurred.As per the provided report, eri occurred on (b)(6) 2019.At the time of the report it was reviewed to retrieve the pump logs to see if there were any other anomalies that might have occurred.Upon review of the provided logs, it was reviewed that it was just eri that occurred with no other anomalies.It was being considered that it appeared like a premature eri case at this point and that they really wouldn¿t know the reason why until the pump gets sent back to the manufacturer for analysis.Scheduling a replacement soon as they won¿t know if eos would occur on the date provided or not was being considered.It was confirmed that there was no programming error.The patient was described as living in a nursing facility so they would have care if anything were to happen with the pump.No patient symptoms were reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The type of report was changed from previously being a reportable malfunction to now a reportable serious injury.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a company representative.The pump was still showing premature elective replacement indicator (eri).The patient required increased monitoring at the facility, travel to and from the medical campus, and would require surgical intervention.Pump replacement was scheduled to occur (b)(6)2019.The pump was planned to be returned to the manufacturer.The patient¿s weight at the time of the event was unavailable.

Manufacturer Narrative

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

Event Description

The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Analysis of the pump identified electrochemical migration across the electrical feed-through insulator.The previously reported evaluation conclusion, result, and method codes no longer apply.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: 8965996
• MDR Text Key: 156638353
• Report Number: 3004209178-2019-17039
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 09/10/2019; 02/12/2020
• Supplement Dates FDA Received: 09/11/2019; 09/18/2019; 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• 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: 29 YR