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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2014, explanted: (b)(6)2018, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 26-oct-2015, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving unknown drug, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain and degen disc disease/herniated disc pain.It was reported that patient was having increased pain and noted that she wasn't getting as much pain relief as she did before.At her refill there was a slight amount of extra drug always in her pump (not to trigger the discrepancy per the healthcare professionals).The rep asked for more information but she was waiting on that.No known factors that may have led or contributed to the issue were reported.The hcp did a dye study and was not able to aspirate the catheter however when he pulled back on her lumbar spine skin he was able to aspirate the catheter.It was assumed to be a kink in the catheter.The catheter was revised in surgery and pictures were taken because of a 90 degree vend in the catheter right when it exited the anchor.The catheter was kinked at the anchor site to a complete 90 degrees bend.It was replaced with an 8782.At the time of this report, the issue was resolved and patient status was alive-no injury.Pump logs and picture of catheter were attached.The log indicated that 25.4 cm of catheter was revised/removed.No further complications were reported.

Manufacturer Narrative

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

Event Description

Patient was receiving fentanyl, 1778.8 mcg/ml concentration at 919.7 mcg/day, bupivacaine, 20.0 mg/ml concentration at 10.341 mg/day dose and morphine, 1.9 mg/ml concentration at 0.9824 mg/day dose via intrathecal drug delivery pump.

Manufacturer Narrative

Product id 8780 (b)(4) implanted: (b)(6)2014 explanted: (b)(6)2018 product type catheter analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer and a device manufacturer representative on 2018-mar-28.It was reported that the patient's medical history included ms, depression and anxiety.The patient's weight was provided.The patient reported that her increased pain had begun in "probably nov." no further complications were reported.

Manufacturer Narrative

Updated/corrected to include report source of health professional instead of company rep.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from consumer indicated there was about six months of the patient telling her healthcare provider (hcp) how much pain she was in, which did not happen when she initially had the pump implanted, her doctor kept increasing her medication.The patient mentioned at her refills during that time, her doctor also noticed when her pump should have been empty, there was a lot of medication left in the pump.The patient mentioned her doctor did fluoroscopy, which determined a ¿problem with the catheter,¿ so she had it replaced.It was also noted in ¿probably (b)(6) 2017" the pain started and a lot of mediation was in the pump when the pump should have been empty.On (b)(6) 2018, fluoroscopy determined there was a problem with the catheter.It was also reported the doctor was having the patient go in weekly as they started her medication at a ¿low level¿ and was slowing increasing to avoid overdose.The patient was currently receiving intrathecal morphine ¿0.7481,¿ fentanyl ¿700.4,¿ and bupivacaine 7.875.¿ it could not be confirmed if the numbers were dose or concentration and the patient did not have further information.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the patient had a big change in pain relief from (b)(6) 2017 fill and (b)(6) 2018.It was noted the patient¿s weight looked pretty stable for her over the past six months at (b)(6).The volumes were provided from the last five fills starting (b)(6) 2017 and the expected residual volume (erv) was 8.3 milliliters (mls) and the actual residual volume (arv) was 14 mls.On (b)(6) 2017 the erv was 4 mls and the arv was 11 mls.On (b)(6) 2017 the erv was 8.9 mls and the arv was 16 mls.On (b)(6) 2018 the erv was 6.6 mls and the arv was 14 mls.Finally, on (b)(6) 2018 the erv was 2.9 mls and the arv was 10 mls.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis of the catheter found a kink in the catheter body.If information is provided in the future, a supplemental report will be issued.

• 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: 7350561
• MDR Text Key: 102801642
• Report Number: 3004209178-2018-05305
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• 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: 54 YR
• Patient Weight: 83