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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Scar Tissue (2060); Convulsion/Seizure (4406); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) and consumer via a company representative (rep) regarding a patient receiving intrathecal lioresal 2000mcg/ml at 246 mcg/day to 100 mcg/day via an implanted pump. It was reported the patient had symptoms of withdrawal on and off since his pump replacement last year (b)(6) 2021 and has had issues every since. Symptoms included itching and increased spasticity, but not severe withdrawal. There were no known environmental, external, patient factors that may have led or contributed to the issue. In the last month, the patient had a cat scan and attempted aspirations to the side board that revealed no flow. It was further reported the patient was taken to the operating room (or) on the date of this report, and the pump pocket opened with no cerebrospinal fluid (csf) through the side port. It was noted there was a large entanglement of catheter in scar tissue that was found at the bottom of the pump pocket surrounding the catheter access port. Large amounts of scar tissue was invading the catheter connector as well. The catheter was cut and still no csf flow. Once the catheter was untangled, and it was cut proximal to the collet, csf began to flow. A new catheter connector was placed with good csf flow, and a new 20 ml pump was placed, and dose reduced from 246 mcg/day to 100 mcg/day. Patient did have an intra-operative seizure. Patient would be admitted to the intensive care unit (icu) because of dose change and intraoperative seizure observed. It was noted the patient¿s old pump was assessed to see if there was the proper amount of medication remaining. There was the exact amount of medication as expected, therefore the pump was delivering medication somewhere. It was unknown if the issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. The patient¿s weight was asked and would not be made available.

Manufacturer Narrative

Continuation of concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter , ubd: 12-aug-2016, udi#: (b)(4). 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13761937
• MDR Text Key: 289462903
• Report Number: 3004209178-2022-03241
• 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,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Followup,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2020
• 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: 03/14/2022 Patient Sequence Number: 1