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

Model Number 8637-20

Device Problem Difficult to Insert (1316)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare provider (hcp) via a company representative regarding a patient receiving morphine (1. 0 mg/ml at 0. 1999 mg/day) and bupivacaine (0. 7 mg/ml at 0. 13995 mg/day) via an implanted pump. The patient¿s medical history included chronic tailbone and leg pain, lumbar 3-4 fusion with hardware, x-stop placement (lumbar), rickets disease as a child, and bilateral knee replacements. It was reported that after the initial implant procedure the patient woke up in recovery and complained of intense burning pain in both arches of her feet. The patient was inconsolable and crying in pain. Anesthesia sedated the patient in recovery to calm her down. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that during the initial implant procedure, the surgeon did have to reposition the spinal needle one time to gain access to the intrathecal space. The patient had a fusion at l3-4. The surgeon inserted the spinal needle above at l2-3. The remain der of the procedure went without difficulty and the catheter had good csf (cerebrospinal fluid) flow and placement. After the implant and in recovery, the surgeon did access the pump¿s cap (catheter access port) to make sure the catheter was patent and the catheter was aspirated without difficulty. The patient was then taken to mri and no abnormalities were found. After the mri and 30-45 minutes in recovery with iv (intravenous) pain medication not helping, the surgeon decided to take her back to surgery and revise the spinal segment of the catheter and fill the pump with medication. It was filled with pfns (preservative free normal saline) during the initial implant. During the catheter revision, the old spinal segment was removed and replaced with a new spinal segment from a revision kit. The surgeon had no difficulty with the catheter insertion. Once the tip was at t10, he anchored and attached the new segment to the existing pump segment. The revised catheter was aspirated and had good flow. The pump was filled with morphine and bupivacaine during the procedure. The patient was taken back to recovery and when she woke up this time, she still complained of burning in the arches of her feet, but it was not as intense. The patient then received a 0. 2 mg single bolus, and this helped with the patient¿s pain. The surgeon gave another 0. 2 mg bolus following the first and the patient stated that the burning pain was ¿letting up¿. The patient was then sent up to the surgical floor of the hospital for overnight observation. Today (b)(6) 2021, the surgeon saw the patient in the hospital and said she was 90% better and was going home. The patient was to have an office follow up visit with the surgeon in about a week. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11259105
• MDR Text Key: 229639007
• Report Number: 3004209178-2021-01733
• Device Sequence Number: 1
• Product Code: LKK
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/01/2021 Patient Sequence Number: 1