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 06/10/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare professional (hcp) regarding a patient receiving dilaudid (1.5 mg/ml at 0.5 mg/day) via an implanted pump.The indication for pump use was failed back surgery syndrome and non-malignant pain.On (b)(6) 2017 it was reported that an alarm was heard.Telemetry confirmed the eri (elective replacement indicator) alarm had occurred.The pump eri appeared to have occurred early based on implant date and flow rate.Per the hcp, the patient was planning to discontinue the use of the pump and they were planning to put saline in the pump today.The hcp was going to check with the doctor so see if he wanted to silence the eri alarm or permanently stop the pump with the pump off passcode.The patient had no symptoms related to the event.No further patient complications have been reported as a result of this event.

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: 6676437
• MDR Text Key: 78698174
• Report Number: 3004209178-2017-13957
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• 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: 06/28/2017
• Date Device Manufactured: 02/24/2011
• 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: 40 YR