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

Model Number 8637-40

Device Problem Mechanical Jam (2983)

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

Event Date 09/13/2017

Event Type  malfunction  

Event Description

Information was received from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain and failed back surgery syndrome.The pump contained fentanyl [50 mcg/ml] at a dose of 12 mcg/day.It was reported a motor stall was seen at initial interrogation.The patient recently had an mri.A motor stall occurred on (b)(6) 2017 at 09:30.The hcp stated the patient left the mri field around 10 am that same day.It had not been less than 2 hours since the patient exited the mri field.The hcp stated their plan was to fill the patient¿s pump with saline and program it to minimum rate due to a pending back procedure the patient would be having in (b)(6).The hcp stated they were still not seeing the motor stall recovery.The hcp stated they would move forward with programming the pump to minimum rate with saline.The hcp stated she would not silence the alarm since it didn¿t bother the patient.No patient symptoms/complications were reported.

Manufacturer Narrative

Updated to reflect the patient's weight at the time of the event.Updated to reflect the information received on 2017-oct-10.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 2017-oct-10 from the patient's healthcare provider (hcp).The patient's weight was reported.It was reported that the issue was resolved pending the explant during the patient's scheduled back surgery on (b)(6) 2017.The patient's pump was refilled with normal saline and programs at minimal rate.No further complications were 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: 6875287
• MDR Text Key: 86638573
• Report Number: 3004209178-2017-19590
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/16/2017
• Date Device Manufactured: 11/18/2013
• 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-0592-2009
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 103