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

Model Number 8637-20

Device Problems Failure To Service (1563); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problem Dyspnea (1816)

Event Date 09/18/2017

Event Type  Injury  

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 healthcare provider (hcp) via a clinical study regarding a patient receiving hydromorphone (12.0 mg/ml at 6.181 mg/day) via an implantable infusion pump.The indication for use was noted as non-malignant pain and postlaminectomy pain.It was reported the patient did not show up for his scheduled refill appointment and did not respond to repeated calls and certified letter.He was hospitalized for dyspnea on (b)(6) 2017 and they were not called until (b)(6) 2017.The device was interrogated and gave results of an empty reservoir alarm as of (b)(6) 2017.They filled the pump with saline due to the inability to be sure the pump was functioning appropriately.The therapy was suspended on (b)(6) 2017.If the patient shows up for his scheduled appointment in a month they will consider a refill with dilaudid after a roller ball study to confirm the pump function.The outcome was noted as ongoing.The etiology was noted as related to the device or therapy and not related to the implant procedure.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study indicated the device diagnosis/clinical diagnosis was empty pump reservoir.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the patient's baseline weight was (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider on 2018-apr-21.It was reported that the patient has severe cardiac issues necessitating a valve replacement, and would not pursue intrathecal therapy until stable.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2018.

• 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: 6900750
• MDR Text Key: 87631750
• Report Number: 3004209178-2017-20232
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/01/2018

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: 12/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/25/2017; 11/07/2017; 04/21/2018; 09/29/2018
• Supplement Dates FDA Received: 10/30/2017; 11/08/2017; 04/26/2018; 10/01/2018
• Date Device Manufactured: 07/03/2013
• 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: 64 YR
• Patient Weight: 76