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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problems Apnea (1720); Dyspnea (1816); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc; lot#: n110829005; implanted: (b)(6) 2008; product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), 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 bupivacaine 18 mg/ml at 8. 99 mg/day and sufentanil 300 mcg/ml at 150 mcg/day via an implanted pump. It was reported the event/difficulty occurred on (b)(6) 2022 during a procedure. A catheter flow study was performed. The patient had to be administered narcan due to possible overdose of medication during procedure and had difficulty breathing. It was further reported the pump was programmed with bridge bolus on (b)(6) 2022 using preservative free normal saline (pfns) to push out all medication from internal tubing and catheter. It took 23 hours and 17 minutes. At greater than that time, the catheter access port (cap) was accessed, and an aspiration was attempted without success. At that point, the doctor felt comfortable pushing dye through to check for leaks. The doctor was able to follow dye without indication of leaks. He then attended to aspirate again, but this time it was successful. Almost at the end of the procedure, the crna stated that something did not seem right. The patient was not breathing on her own and then they had to start bagging the patient and eventually administered narcan. After the medication was administered, there were indications the patient was breathing on her own. It was unknown if there were any environmental, external, patient factors that may have led or contributed to the issue. Narcan was administered and patient monitored in post anesthesia care unit (pacu). Finally transferred to local hospital for observation. Surgical intervention did not occur and was not planned. It was unknown if the issue was resolved, and the patient¿s status was ¿alive- no injury¿. The patient¿s weight and medical history were asked but unknown.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13772430
• MDR Text Key: 290092840
• Report Number: 3004209178-2022-03318
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2015
• 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: 03/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/21/2014
• 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: 03/15/2022 Patient Sequence Number: 1