MAUDE Adverse Event Report: MEDTRONIC 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); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8781, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving fentanyl (1948.3 mcg/ml at 1415.7 mcg/day), bupivacaine (20.0 mg/ml at 14.533 mg/day), and morphine (5.4 mg/ml at 3.9239 mg/day) via an implanted pump.The indication for use was non-malignant pain and lumbar radiculopathy.It was reported the patient had a catheter access port (cap) contrast study performed on (b)(6) 2018, and the catheter was followed from the pump to the spine with no leaks seen.Contrast could be seen exiting the intrathecal catheter tip at the t8 level and dispersing freely without restriction.A catheter kink was detected around the anchor site.The clinical diagnosis was increased pain.It was indicated the event was related to the device or therapy and unlikely related to the implant procedure.It was noted the system would require surgical revision.The outcome was noted as ongoing.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the cause of the catheter kink was not dete rmined.It was noted surgery was scheduled for the future and as of (b)(6) 2018 the event was ongoing.The patient's weight was not measured.

Manufacturer Narrative

Product id (b)(4) serial# (b)(4) implanted: (b)(4) 2014: product type catheter udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the catheter was explanted/replaced on (b)(4) 2018, and will be returned to the manufacturer for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

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 company representative (rep) indicated she was going to be assisting the doctor with a catheter revision this afternoon on (b)(6)2018.It was found to be kinking at the catheter anchor.This patient had a recent catheter access port (cap) dye study and the physician was concerned.When the physician pulled down on the catheter he could see dye moving through and when relaxed it would not go through the catheter.The kink was confirmed via dye study.Symptoms were not reported at this time.The event date was asked, and unknown.The rep called back after the catheter revision was completed.A picture of the kink was provided.The kink was noted at the distal or intrathecal end of the anchor.The doctor did state he inserted this catheter at a little more of an angle due to the patient¿s size.The physician noted a little more torque on the catheter at the connection with the pin connector and collets.The patient had complaints of a gradual change in therapy prior to this finding.She was unsure when the change in therapy occurred.Some of the reservoir volumes were provided and on (b)(6)2018 the expected residual volume ( erv) was 5.1 mls (milliliters) and the actual residual volume (arv) was 10 ml.On (b)(6)2018, the erv was 3.9 mls and the arv was 9 mls.The catheter was received for analysis.Additional information was also received from a healthcare professional (hcp) via a clinical study indicated the catheter portion was specified as the intrathecal/spinal portion.The event was related to the device or therapy and not related to the implant procedure.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 via a manufacturer representative on 2018-apr-06.It was reported that the patient's diagnoses included lumbosacral disc degeneration, and lumbar intervertebral disc disorders with radiculopathy.The patient's allergies included red dye, amoxicillin, latex, and penicillin (pcn).Comorbidities included seizure disorder, brain aneurism, multiple sclerosis (ms), hypertension (htn), diabetes mellitus (dm), and asthma.It was indicated that the catheter tip was at t9 and the implant location was the right upper buttock.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated that the outcome of the event resolved without sequelae on 2018 (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

The catheter was returned, and analysis found a compressed area in the catheter body and observed 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): 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: 7285506
• MDR Text Key: 100546632
• Report Number: 3004209178-2018-03671
• 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: 06/05/2018

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: 11/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 04/05/2018; 04/03/2018; 04/06/2018; 05/22/2018; 05/31/2018
• Supplement Dates FDA Received: 03/23/2018; 04/06/2018; 04/09/2018; 04/16/2018; 05/23/2018; 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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: 42 YR