MAUDE Adverse Event Report: MDT 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 05/01/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional via a company representative regarding a patient receiving bupivacaine (10 mg/ml at 1.2 mg/day) and morphine (10 mg/ml at 1.2 mg/day) via an implanted pump.The indication for pump use was failed back surgery syndrome and non-malignant pain.On 03-oct-2017 it was reported that telemetry confirmed a non-critical alarm occurred due to eri (elective replacement indicator).The eri was premature and occurred sometime since the last pump refill in (b)(6) 2017.The reporter did not have the logs, but eri likely occurred (b)(6) 2017 based on the schedule to replace pump by date of (b)(6) 2017.The patient had no symptom change and did not report hearing an alarm.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The pump was returned by an unknown source to the manufacturer for analysis on (b)(6) 2017.The returned pump logs indicated the device had been examined on (b)(6) 2017, with the last changing occurring on (b)(6) 2017.The logs indicated the elective replacement indicator (eri) occurred on (b)(6) 2017, with a message to replace the pump by (b)(6) 2017.No further information was provided.

Manufacturer Narrative

Analysis found that there was high resistance in the battery.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.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: 6914475
• MDR Text Key: 88232704
• Report Number: 3004209178-2017-20580
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR