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

Model Number 8637-40

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient receiving unknown morphine 5mg/ml for a total flex dose of approximately 2.5mg/day via an implantable pump for spinal pain and post laminectomy pain.It was reported the patient and healthcare professional (hcp) reported motor stalls.The logs did not indicate motor stalls had occurred.There was no known factors that may have caused or contributed to the issue.Although it was stated that no diagnostics/troubleshooting occurred, it was also noted that the logs did not indicate motor stalls indicating the logs were read/checked.Actions/interventions included pump replacement on (b)(6) 2017, and reported that surgical intervention did occurred as the pump was replaced.It was noted that the pump will be returned for analysis.It was noted that the issue was resolved at time of report, and patient's status at time of report was "alive-no injury." no symptoms reported.The patient's weight was asked, but unknown.Patient's medical history included chronic intractable back pain.No further complications were reported/anticipated.

Manufacturer Narrative

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 received from manufacturer representative (rep) on 2017-aug-18 reported that they sent the pump back to manufacturer for analysis.No tracking information was provided.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 on 2017-aug-02 reported the pump will be returned for analysis.No further complications were reported/anticipated.

• 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: 6759562
• MDR Text Key: 81572439
• Report Number: 3004209178-2017-16036
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• 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: 54 YR