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 10/30/2016

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 consumer regarding a patient receiving unknown drug via an implanted pump. The indication for use was intractable spasticity and cerebral palsy. It was reported the patient's pump was interrogated on (b)(6) 2016 and it noted 16 months until eri. The pump was then interrogated on (b)(6) 2016 and it noted eri occurred on (b)(6) 2016. The pump needed to be replaced before (b)(6) 2017. The patient's pump was explanted on (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additionalinformation was received from a healthcare provider on 2018-mar-09. It was reported that the patient did not experience any symptoms related to the premature eri, and it was specified that there were no withdrawal symptoms. Regarding the cause of the premature eri, it was noted that eri went from 15 months to 90 days since the patient's last refill on (b)(6) 2016. It was noted that the issue was not resolved until replacement on (b)(6) 2017 (note: this conflicts with the previous report that the pump was explanted on (b)(6) 2017). No further complications were reported or anticipated.

• 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: 7286598
• MDR Text Key: 100600807
• Report Number: 3004209178-2018-03711
• 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

• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/10/2011
• 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: 02/21/2018 Patient Sequence Number: 1