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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Component Missing (2306); Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Irritability (2421); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 05/16/2020

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving gablofen via an implantable pump for unknown indications for use. It was reported that the patient experienced baclofen withdrawal symptoms: increased tone, irritability, insomnia, and increased involuntary body movement. The patient's symptoms led them to be an in-patient in the hospital. The increased tone was thought to be related to the low volume in pump due to an upcoming alarm date but the symptoms continued. The medication was increased from 157 to 580 mcg/day. Multiple volume discrepancies were noted to have occurred: (b)(6) 2021 the expected reservoir volume (erv) was and the actual reservoir volume (arv) was 10 ml, (b)(6) 2021 erv was 2. 2 ml and the arv was 9. 1ml, (b)(6) 2021 the erv was 5. 1 ml the arv was 10. 1 ml, (b)(6) 2021 the erv was 5. 8 ml and the arv was 12 ml, (b)(6) 2021 the erv was 3. 6 ml and the arv was 10. 5 ml and (b)(6) 2022 the erv was 3. 4 ml and the arv was 11 ml. A dye study was completed on (b)(6) 2021 and the catheter access port was unable to ab aspirated. The issue was ongoing. Catheter replacement was not completed at this time due to concern of hospitalization during covid surge.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-feb-2021, 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: 13758118
• MDR Text Key: 290157212
• Report Number: 3004209178-2022-03196
• 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: Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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: 08/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/14/2019
• 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: 03/14/2022 Patient Sequence Number: 1