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

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Cerebrospinal Fluid Leakage (1772); Scar Tissue (2060); Seroma (2069); Headache, Lumbar Puncture (2186)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 02-feb-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal morphine 2.5 mg/ml at 0.4821 mg/day, clonidine 500 mcg/ml at 96.41 mg/day, and bupivacaine 10 mg/ml at 1.928 mg/day via an implanted pump for non-malignant pain.The event/difficulty occurred on (b)(6) 2018 during normal use.A possible spinal leak was reported.The patient reported having a headache since after her pump was replaced in ((b)(6) 2018) and the catheter was revised.The patient developed a golf ball size mass to one side of her spine where the incision scar of the catheter insertion and anchoring was located.The doctor believed the cause of the headaches and the mass on the back was related to a spinal catheter that was left, but not tied off because he thought it was not flowing/working.Environmental/external/patient factors have may have led or contributed to the issue was unknown as well as diagnostics/troubleshooting performed.The patient was taken to surgery and an incision was made at the old scar.Spinal fluid was suctioned, and the abandoned spinal catheter was located immediately.The end of the spinal catheter was folded, and two sutures were used to tie off the catheter.It was further reported the patient was taken to surgery to stop the spinal fluid leak.The patient had a golf ball size mass along the spine and it was believed to be caused by a spinal catheter left behind, but not tied off.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ other medications the patient was taking at the time of the event were unable to obtain, not available.The patient¿s weight was asked and unknown and would not be made available (legal/confidential reason).The patient¿s medical history included chronic back pain.Additional information was received from a company representative (rep) on 2018-jun-22 indicated they were not aware of any device or therapy issues that led to the pump replacement on (b)(6) 2018.The rep reported following the (b)(6) replacement the patient began experiencing the headaches and developed the golf ball size mass to one side of her spine.Therefore, the patient went back into surgery on (b)(6) 2018 and the patient was opened-up to determine what was causing the issue.It was indicated that was when the rep became involved with the report.The rep reported that during the revision the doctor told her that when the pump was replaced on (b)(6) 2018, they did not think the catheter was working so they left the catheter implanted due to scar tissue without tying the catheter off.The rep did not know why the doctor thought the catheter was not working on (b)(6) 2018.The rep did not have access to device records to confirm which device had been left in the patient, but it was reviewed that it was most likely the 8598a model catheter with serial number (b)(4).During the revision on (b)(6), the hcp identified that the catheter was leaking csf fluid which was causing the headaches and the mass to form.The catheter was then tied-off as reported.It was unknown how the patient was doing following the (b)(6) 2018 revision.No further information was provided.

• 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: 7638933
• MDR Text Key: 112369938
• Report Number: 3004209178-2018-14378
• 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: Physician
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• 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: 06/20/2018
• Date Device Manufactured: 03/27/2018
• 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: 60 YR