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

Model Number 8637-20

Device Problems Device Alarm System (1012); Premature End-of-Life Indicator (1480); Data Problem (3196)

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

Event Date 03/25/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer's representative and a healthcare provider regarding a patient who was receiving 2100mcg/ml baclofen at 625mcg/day via an implantable infusion pump for intractable spasticity and post spinal cord injury/spinal cord disease.It was reported that the pump was last filled on (b)(6) 2017 and elective replacement indicator (eri) showed 9 months.It was stated that the pump started to alarm on saturday (b)(6) 2017 and when the patient read the pump it said "eos occurred" and showed an "eri of (b)(6) or something like that." it was stated that pump alarmed every hour on the hour and sounded like "beep beep beep like a watch." it was stated the patient was "doing ok" symptoms wise.It was stated oral baclofen was ordered for the patient.No further complications were anticipated/reported.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6449504
• MDR Text Key: 71468881
• Report Number: 3004209178-2017-06760
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Date Device Manufactured: 01/21/2011
• 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-2276-2009
• Patient Sequence Number: 1
• Patient Age: 34 YR