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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Nausea (1970); Therapeutic Response, Decreased (2271)

Event Date 01/01/2017

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 consumer regarding a patient who was receiving baclofen and dilaudid at an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported that the patient thought something had been wrong with her pump since (b)(6) 2017.The pump was not alarming when it was empty like it should since (b)(6) 2017.It was alleged that the medication was not going through the pump as it should.Saline was put in the pump on (b)(6) 2017 and the patient was told that day the pump had been out of medication for two weeks.It was noted that the patient had withdrawal symptoms starting on (b)(6) 2017 with an upset stomach.Additionally, it was noted that the patient fell 2 to 3 times in the past month and she fell on her spine in one of the falls.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received on 2017-jul-27 reported the patient called stating they spoke to the healthcare professional (hcp) today ((b)(6)2017) and the hcp stated the managing hcp called and was told that the patient did not call on (b)(6) 2017.It was noted that the hcp will not fill the patient's pump with medication and has saline in the pump.The patient was still going through withdrawal.It was reviewed that the hcp was the one managing the patient's care and it is the hcp that the patient needs to work with to get the pump filled.No further complications were reported/anticipated.

• 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: 6743961
• MDR Text Key: 81143607
• Report Number: 3004209178-2017-15578
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 07/31/2017
• Date Device Manufactured: 12/14/2012
• 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 Age: 50 YR