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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

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

Event Date 12/22/2018

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 health care professional (hcp) via a device manufacturer representative regarding a patient receiving gablofen (2000 mcg/ml at 1023.9 mcg/day) via an implantable infusion pump.It was reported that the patient's pump motor stalled and recovered several times starting on (b)(6) 2018.The patient's caregiver heard the critical alarm and brought the patient to the hospital.The patient was admitted on (b)(6) 2018.The pump was replaced on (b)(6) 2018.The pump was 7 months away from its elective replacement indicator (eri).The catheter was aspirated successfully during the pump replacement.The hospital was in possession of the pump at the time of the report, and they were notified that the pump should be returned for analysis.The issue was considered resolved.The patient's weight was unknown.The patient's status at the time of the report was alive - no injury.No patient symptoms were reported.No further complications were reported.

• 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: 8205306
• MDR Text Key: 131701125
• Report Number: 3004209178-2018-28511
• 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
• Type of Report: Initial
• Report Date: 12/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• 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: 12/26/2018
• Date Device Manufactured: 10/03/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR