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

Model Number 8637-20

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 09/05/2018

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 the healthcare provider (hcp) indicated the cause of the premature elective replacement indicator (eri) was not determined. It was noted they would be replacing the reservoir since they did not know what else to do. 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 healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal unknown morphine 35 mg/ml at 13 mg/day via an implanted pump for non-malignant pain. It was reported the patient was last seen in (b)(6) 2018 and the elective replacement indicator (eri) showed 28 months. The non-critical alarm occurred over the weekend and showed that eri occurred. This would appear to be a premature eri based on the information. The rep was redirected to follow-up with the healthcare provider (hcp) to review options. Patient symptoms were not reported. The event date was (b)(6) 2018. The rep called back inquiring if he silenced the eri alarm if the pump would still alarm when end of service (eos) occurred. It was reviewed only active alarms could be silenced so they would have to wait until eos occurred to silence the alarm. 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

Additional information was received from the hcp via the rep. It was reported that pump was completely explanted and replaced, was in the possession of the rep, and would be returned to the manufacturer. The issue was resolved. The patient status was 'alive - no injury. Logs indicated the eri alarm occurred 2018-(b)(6). The logs indicated to replace the pump by 2018-(b)(6). No further complications were reported.

Manufacturer Narrative

Destructive analysis identified electrochemical migration across the electrical feed-through insulator. Medtronic developed a design change to reduce feed-through shorting and received regulatory approval for the change. Medtronic began distributing pumps with this design change in (b)(6) 2016. 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: 7868897
• MDR Text Key: 121040451
• Report Number: 3004209178-2018-20443
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/12/2018 Patient Sequence Number: 1