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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problems Muscle Weakness (1967); Weakness (2145); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer on (b)(6) 2018 regarding a patient receiving hydromorphone (dose and concentration unknown) via an implanted infusion pump. The indication for use was non-malignant pain. The patient mentioned a previous battery replacement, however it was noted that the battery longevity was within specification. It was reported that the patient's pump was filled on thursday ((b)(6) 2018) and the patient was able to use their personal therapy manager (ptm) normally on friday ((b)(6) 2018), but on saturday morning ((b)(6) 2018) the patient started seeing a 8476 code, indicative of a motor stall. It was noted that the patient was currently on their way to the hospital because they were feeling sick and weak. The patient asked if diarrhea could be a sign of withdrawal. No further complications were reported or anticipated.

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: 7739929
• MDR Text Key: 116261898
• Report Number: 3004209178-2018-17069
• 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: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial