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

Model Number 8637-20

Device Problems Kinked (1339); Occlusion Within Device (1423); Device Displays Incorrect Message (2591); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2018, udi#: (b)(4).Date of event is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional and a patient who was receiving fentanyl and dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain.It was reported that every time the patient went in for a pump refill or increase she kept telling the doctor that she hadn't been getting pain relief, which was why he had increased it.The patient would wake up because of the pain.Recently the doctor checked the patency of the catheter with a dye test, and he was not able to aspirate anything from the catheter which led him to believe it could be a tear or plug and that the pump was pushing it through, but not as reliably as she would want it to be.The patient would have to wait for two weeks to undergo a catheter revision (scheduled for the (b)(6) due to the surgery schedule).The patient was concerned about having a malfunctioning unit in her body for two weeks.The patient had an l5 s1 fusion that was experimental and they went through the back and through the stomach, put two titanium cages in and used her "hip bone as screws".The surgery went wrong, and her hip bone was wrapped around her sciatic nerve so that made matters much worse.This was prior to pump implant.The patient was constantly in sciatica, had groin pain that made her feel like she had to urinate, had vaginal pain, had a recent mri (magnetic resonance imaging) that showed (neuro?) spores, felt like she had (b)(6) of weight above her groin, thought her pump was out of medicine, thought her catheter needed to be changed, and felt uncertain.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative on (b)(4) 2018.A confirmed catheter event occurred.It was reported that the spinal segment of the catheter was occluded.The issue was diagnosed during a revision.The revision was completed on (b)(6) 2018 and the spinal segment of the catheter was replaced.The pump was being used to deliver fentanyl [3000 mcg/m] at 150 mcg/day and dilaudid [ 20 mg/ml] at 1 mg/day.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional via manufacturer representative.It was reported that the physician attempted to aspirate the catheter via the catheter port access prior to revising the spinal segment.This was not successful.Subsequently, the spinal segment was replaced, the entire catheter was successfully aspirated, the pump was refilled, and was operating normally.No images pertaining to the event were available.A possible kink was observed in the catheter immediately distal to the anchor point.The distal segment was discarded after the procedure.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: 7551449
• MDR Text Key: 109482779
• Report Number: 3004209178-2018-12083
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/06/2018; 06/07/2018
• Supplement Dates FDA Received: 06/07/2018; 06/08/2018
• Date Device Manufactured: 11/18/2016
• 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: 65 YR