MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC (INTRATHECAL PAIN PUMP) SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

Patient had continuous complaints of cyclical withdrawal symptoms with her medtronic pain pump.A referral was made on (b)(6) 2021 to have it replaced, but the symptoms had been over the last approximate 6 months when the battery end of life was still appropriate.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC (INTRATHECAL PAIN PUMP) SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 13479727
• MDR Text Key: 285493753
• Report Number: MW5107268
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White