MAUDE Adverse Event Report: AVERY IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Type  Injury  

Event Description

Healthcare professional reported patient having experienced abdominal discomfort and pain.Patient described the discomfort as a feeling like their stimulation is on.Patient had been implanted in 2008 and the device has not been in use for some time.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR
• Type of Device: IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR
• Manufacturer (Section D): AVERY
• MDR Report Key: 17516382
• MDR Text Key: 321048462
• Report Number: MW5123331
• Device Sequence Number: 1
• Product Code: GZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1