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 07/14/2017

Event Type  malfunction  

Event Description

Information was received from a health care professional (hcp) regarding a patient who was receiving baclofen (concentration of 2000 mgc/ml at a dose of 529.5 mcg/day) via intrathecal drug delivery pump for intractable spasticity and head/brain injury.It was reported that the non-critical alarm was heard and confirmed by telemetry.The hcp confirmed that an elective replacement indicator (eri) was occurring.The eri was not expected.The hcp reported that on the last refill (b)(6) 2017, the eri was 7 months and the eri occurred on (b)(6) 2017.Technical services reviewed scheduling a pump replacement.The hcp would contact the physician to discuss the pump replacement.Technical services also discussed if premature eri occurred then premature end of service could occur.No patient symptoms were reported.No further complications were reported.On (b)(6) 2017, a manufacturer representative was notified about the event.

• 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: 6909580
• MDR Text Key: 89477341
• Report Number: 3004209178-2017-20310
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• 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: 09/22/2017
• Date Device Manufactured: 01/31/2011
• 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 Age: 34 YR