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); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Muscular Rigidity (1968)

Event Date 06/17/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving baclofen (500 mcg/ml at 99 mcg/day) via an implantable pump. It was reported that at the scheduled pump refill on (b)(6) 2022, the physician found 18 ml of baclofen in the pump's reservoir while the expected volume was 1. 8 ml. Regarding diagnostics/troubleshooting performed, it was indicated that reading notes, no abnormal events were reported. At the last refill on (b)(6) 2022, there was no anomaly during refill. The patient presented stiffness. The physician was considering arranging a session to check for possible kinking of the catheter with the contrast medium. Factors that may have led or contributed to the issue were unknown. The issue was not resolved as of (b)(6) 2022. The patient's medical history, gender, age, and weight at the time of the event was unknown or would not be made available. Additional information was received from a foreign healthcare provider via a company representative on 2022-jun-21. On (b)(6) 2022 a rotor test showed no abnormalities. It was further noted that on the other hand, direct access to the catheter revealed a catheter obstruction. A catheter revision was to be carried out in july.

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot#: unknown, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: unknown. 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: 14758504
• MDR Text Key: 295034595
• Report Number: 3004209178-2022-07927
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2021
• 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: 07/15/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/15/2020
• 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: 06/21/2022 Patient Sequence Number: 1