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

Model Number 8637-40

Device Problems Protective Measures Problem (3015); Data Problem (3196)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2017

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 consumer via a manufacturer representative regarding a patient receiving morphine with an unknown dose and concentration and bupivacaine with an unknown dose and concentration via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome.It was reported the pump went into safe state.It was unknown what factors may have caused, contributed, or led to the issue.Diagnostics/troubleshooting and actions/interventions performed included pump was on minimum rate.It was noted that the issue was not resolved at time of report.It was noted that surgical intervention did not occur, but surgical intervention was planned, but not yet scheduled.The patient's weight was unknown.Patient's status at time of reported was "alive-no injury." event date was noted as (b)(6) 2017.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 manufacturer representative (rep) on 2017-jul-21 reported the cause was still undetermined.The pump will be returned as soon as it is replaced/explanted.There has not been a surgery scheduled that the rep knew of at this point.No further complications were reported/anticipated.

Manufacturer Narrative

Device code (b)(4) no longer applies to the pump and instead (b)(4) applies to the pump.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient.It was reported the patient had a pump replacement due to the pump shutting off 11 months early.The patient reported they went through morphine withdrawals for 2 weeks.The healthcare provider stated they never had a pump where this happened and didn't know why it happened.No further complications were anticipated/reported.

• 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: 6712128
• MDR Text Key: 80007404
• Report Number: 3004209178-2017-14801
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Date Device Manufactured: 04/25/2011
• 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): Required Intervention
• Patient Age: 61 YR