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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Numbness (2415); Spinal Cord Injury (2432); Ambulation Difficulties (2544); Spinal Arachnoiditis (4416); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-aug-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative regarding a patient receiving morphine (10. 0 mg/ml at 0. 8 mg/day) and bupivacaine (10 mg/ml at 0. 8 mg/day) via an implanted pump. It was reported the pump had been turned off early in (b)(6) when the patient had surgery to remove the catheter due to numbness and paralysis of their lower extremities. According to the patient, they were admitted into the hospital, on (b)(6) 2020, and taken to surgery, on (b)(6) 2020, to remove the it catheter. It was noted the pump was turned off at that time. After interrogating the pump post mri, it was found to still be programmed at a simple continuous mode. However, motor stalls were present in the interrogation report on (b)(6) 2020. The current status of the catheter location was unknown. According to the hospital post op note, it stated that the catheter was removed from the intrathecal space, however, the exact location and existence of the catheter was unknown. There were no known factors known. It was noted the issue was resolved.

• 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
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 10845122
• MDR Text Key: 216416382
• Report Number: 3004209178-2020-20049
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/20/2019
• 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: 11/16/2020 Patient Sequence Number: 1