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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

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

Event Date 06/19/2017

Event Type  malfunction  

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 health care professional regarding a patient who was receiving bupivacaine (concentration 2mg/ml, dose 0.8930 mg/day) and morphine (concentration 1 mg/ml, dose 0.4465 mg/day) via an implantable pump for failed back surgery syndrome and spinal pain.On this report date, a motor stall was seen at initial interrogation; the patient recently had a magnetic resonance imaging scan done due to an unrelated issue.The scan was to assess the patient's sudden back pain and it was confirmed that the pump was not suspected to be the problem, there was no volume discrepancy or anything to indicate that the pump was the cause for the pain.A motor stall recovery was not noted, the patient had only been out of the mri field for ~1hr and the pump was running at a slower rate.The mri was a closed bore system.It was reviewed that they should continue checking the logs until a recovery is noted.No symptoms reported.Event date for the mri was (b)(6) 2017.The health care professional called back and indicated it had been 2.5hrs since patient left the mri field and they were not seeing a stall recovery yet.It was recommended to check the logs every 20-30 min until a stall is noted.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare professional on 2017-jun-29 reported the pump was checked every 1/2 hours until a re covery occurred.A recovery occurred on (b)(6) 2017 at 20:00.The patient's weight was (b)(6) pounds.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: 6684159
• MDR Text Key: 78983312
• Report Number: 3004209178-2017-14146
• 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: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Date Device Manufactured: 11/12/2013
• 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#Z-0592-2009
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 78