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

Model Number 8637-20

Device Problems Nonstandard Device (1420); Pumping Stopped (1503); Mechanics Altered (2984)

Patient Problems Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359); Sleep Dysfunction (2517)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2018-july-13, information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving bupivacaine (2 mg/ml, 0.863 mg/day) and morphine (3 mg/ml, 1.3 mg/day) via an implantable pump for non-malignant pain and cervical/neck.On (b)(6) 2018, initial interrogation of the patient's pump indicated a motor stall occurred.The hcp denied any electromagnetic interference (emi), magnetic interaction, or mris.The rep indicated that the patient heard their pump alarming and was seen in the emergency room (er) with withdrawal symptoms; nausea, insomnia, flu-like symptoms and increased pain.Pump status and/or event log report showed motor stall occurred, motor stall (active), motor stall and recovery, and stopped pump period may exceed tube set.No further information was provided at this point.

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: 7694291
• MDR Text Key: 114587468
• Report Number: 3004209178-2018-15921
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: 07/14/2013
• 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: 07/13/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• Date Device Manufactured: 01/16/2012
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Age: 79 YR