MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Output Problem (3005)

Patient Problem Aspiration Pneumonitis (4455)

Event Date 07/31/2021

Event Type  Injury  

Event Description

Baclofen pump synchromed ii 8637-20 failed at 6 years resulting in horrible withdrawal, aspiration pneumonia and 7 days of hospitalization including surgery to replace pump.Fda safety report id# (b)(4).

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 12331716
• MDR Text Key: 267080203
• Report Number: MW5103288
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 58