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 04/28/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient receiving lioresal (baclofen) with an unknown dose and concentration via an implantable pump for intractable spasticity and cerebral palsy.It was reported premature elective replacement indicator (eri).It was noted that during a refill appointment they noticed the patient had eri.No diagnostics/troubleshooting was performed.It was noted that the healthcare professional (hcp) alerted the surgeons hcp to request an expedited surgery for pump replacement.It was noted that the pump replacement will occur on (b)(6) 2017.It was noted the issue was not resolved at time of report, and patient's status at time of report was "alive-no injury." it was noted that surgical intervention did not occur, but was planned and scheduled for (b)(6) 2017.No other details were known at this time.The patient's weight was unknown.No further complications were reported/anticipated.

Manufacturer Narrative

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: 6533769
• MDR Text Key: 74062116
• Report Number: 3004209178-2017-09365
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Date Device Manufactured: 06/03/2011
• 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: 35 YR