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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Fall (1848)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8782, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via manufacturer representative from a healthcare professional (hcp) and a patient who was receiving fentanyl (50 mcg/day, 50 mcg/ml) via intrathecal drug delivery pump for spinal pain.It was reported that the patient had a fall.There had been a progressive csf (cerebrospinal fluid) leak from the spinal incision, which may have been caused by the fall.The spinal incision was opened and explored due to the ongoing csf leak.The hcp stated that there was a risk of infection so they decided to explant the spinal segment and close the catheter track.Pocket exploration and a pocket revision were performed.The pump and pump segment were left in patient and the hcp would return at a future date to re-implant the spinal segment of the catheter.The explanted catheter would not be returned as the customer refused.The pump was turned to minimum rate.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.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: 7321710
• MDR Text Key: 101795522
• Report Number: 3004209178-2018-04626
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• 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: 03/06/2018
• Date Device Manufactured: 01/31/2018
• 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: 44 YR