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

Model Number 8637-40

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Stenosis (2263); Arachnoiditis, Spinal (2390)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Other components include: product id 8709sc lot# serial# (b)(4) implanted: (b)(6) 2011, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Product id: 8780, serial# (b)(4), product type: catheter.

Event Description

Information was received from a healthcare provider via a manufacturer's representative regarding a patient who was receiving 20000 mcg/ml of fentanyl at 2500 mcg/day via an implantable pump for spinal pain.On (b)(6) 2017, it was reported that the hcp was unsuccessful at inserting a new catheter during a pump replacement surgery.The hcp was unable to identify cerebral spinal fluid with the needle though they felt that they were where they should be.The hcp was also unable to thread the catheter and suspected that it might be due to stenosis or arachnoiditis.A new catheter was not implanted.Rather, the old spinal segment was left in place and the segment from the anchor to the pump was replaced with another catheter.The hcp was still unable to establish csf backflow.However, the patient had a "clear and food effect" from the bolus that was programmed at 6 am on (b)(6) 2017.No symptoms related to the event were reported.Additional information was received on 2017-aug-07 from the manufacturer's representative.The initial reporter was confirmed to be the patient's pump managing physician.The opened, but unused catheter reportedly would not be returned as it was not defective.The cause of the lack of csf flow was not determined.The patient was reportedly receiving effective therapy.The rep noted that they would not be investigating the cause of the lack of csf flow further and the patient's weight would not be made available.No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6795715
• MDR Text Key: 82753781
• Report Number: 3004209178-2017-17512
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• 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: 08/02/2017
• Date Device Manufactured: 04/07/2017
• 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: 68 YR