MAUDE Adverse Event Report: MEDTRONIC, INC. PUMP SYNCHROMED 2ML; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number SNGP403755H

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2019

Event Type  Injury  

Event Description

Her pump alarm went off two days ago indicating a form of motor malfunction which was not reversible by means of reprogramming.Fda safety report id # (b)(4).

• Brand Name: PUMP SYNCHROMED 2ML
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9437627
• MDR Text Key: 170315105
• Report Number: MW5091516
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SNGP403755H
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 66