MAUDE Adverse Event Report: MDT 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 02/05/2019

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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine [10 mg/ml] at a dose of 7.107 mg/day, ropivacaine [4.0 mg/ml] at a dose of 2.8428 mg/day, and clonidine [375 mcg/ml] at a dose of 266.51 mcg/day via an implantable pump.The indication for use was not provided.It was reported on (b)(6) 2019 that elective replacement indicator (eri) was noted during a planned refill, which was indicated to be "early eri." it was noted the pump was implanted on (b)(6) 2014.Pump replacement was planned for (b)(6) 2019.Event logs examined on (b)(6) 2019 at 08:48 submitted with the report showed that eri had occurred on (b)(6) 2018.Event logs from a previous session showing the expected eri leading up to before it occurred were requested but not yet provided.It was reported that the pain nurse did not think that the pump was ever programmed with a flow rate greater than 1 ml per day but was not 100% sure.No further complications were reported or anticipated.

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

Additional information received indicated that the eri at a previous session was unavailable.The pump was replaced on (b)(6) 2019 instead of (b)(6) 2019 as scheduled and was returned for analysis.

Manufacturer Narrative

Analysis identified electrochemical migration across the electrical feed-through 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): 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: 8370425
• MDR Text Key: 137152467
• Report Number: 3004209178-2019-03985
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 05/02/2019
• Supplement Dates FDA Received: 03/18/2019; 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR