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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)

Patient Problem Muscular Rigidity (1968)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 05-sep-2020, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-2020, 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 regarding a patient receiving baclofen (2000 mcg/ml at 1289 mcg/day) via an implanted pump.The patient¿s medical history was noted to be motor vehicle accident and quadriplegic.The indication for pump use was intractable spasticity.It was reported that the patient¿s therapy efficacy was lacking, and the patient was becoming more rigid despite a large daily dose with flex dosing.A ct dye study was performed, and they were unable to aspirate from the catheter.It was noted that the hcp was very unhappy with the lack of fluoroscopy discovery with the catheter and it was extremely hard to view under x-ray.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The catheter was replaced.The pump dose was decreased to 800 mcg/day.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12173057
• MDR Text Key: 261687852
• Report Number: 3004209178-2021-10883
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• 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: 07/12/2021
• Date Device Manufactured: 12/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR