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); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Swelling (2091); Malaise (2359)

Event Date 04/01/2018

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 consumer regarding a patient receiving morphine 10mg/ml at 1.79mg/day via an implantable pump.The indications for use were non-malignant pain and failed back syndrome-other.The patient reported that he thinks his pump stopped over a month ago and the patient had been having problems ever since.The patient stated he was swollen up and was having shortness of breath.The patient was physically fit and had never had this problem before.The patient couldn¿t exercise.The patient stated he didn¿t think the pump had been working and wanted to have it removed.The patient¿s physician was not available until (b)(6).The patient planned to follow up with their healthcare provider.No further complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer.The patient was receiving morphine(1.6 mg/day) at unknown concentration and clonidine at unknown concentration and dosage.It was reported that the patient had been sick the last three months.The pump started beeping in (b)(6) and his roommate noticed the beeping.The patient did not notice the alarm since he had constant ringing in his ear which was unrelated to device or therapy.At first, the alarm was thought to be from the phone.The patient said that it was a single tone which switched over to a dual tone and the it was unknown when the tone switched.The beep was real faint at the time of the report.It was stated that he was out of breath.On (b)(6) 2018, the patient got filled up and the healthcare provider (hcp) withdrew out twice as much liquid as supposed to have in the pump and therefore the patient knew the pump hadn't been working.The patient had been in and out of hospital twice in (b)(6).The patient got tired walking around the house which also started in (b)(6).The patient did not need the pump anymore.No interve ntion was mentioned.No further complication was 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7513745
• MDR Text Key: 108233341
• Report Number: 3004209178-2018-10886
• 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,Followup
• Report Date: 10/04/2018

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: 02/14/2013
• 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: 05/14/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 08/08/2018
• Supplement Dates FDA Received: 07/10/2018; 10/04/2018
• Date Device Manufactured: 08/24/2011
• 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
• Patient Age: 57 YR