MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; NEUROSTIMULATOR

Model Number 1101

Device Problem Wireless Communication Problem (3283)

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

Event Date 06/05/2020

Event Type  malfunction  

Event Description

The patient's charging device would not connect to the ipg (neurostimulator).Several different charging devices were used in an attempt to connect to the ipg.Also attempted to rotate the charging device in different orientations.The issue was unable to be resolved.The implanting physician mentioned during the post-operation follow up appointment that they implanted the ipg no more than 2 cm.The physician palpated for the ipg and was able to locate it.Impedances were checked and observed to be fine.The physician decided to schedule the patient for a pocket revision on (b)(6) 2020.The clinical specialist was able to meet with the patient prior to the surgery on (b)(6) 2020.The patient was finally able to get a connection tone between the charging device and ipg.On (b)(6) 2020, the physician went ahead with the surgery to replaced the patient's ipg with a new ipg.

• Brand Name: AXONICS
• Type of Device: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10226137
• MDR Text Key: 202789462
• Report Number: 3002968685-2020-00053
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: 10810005340066
• Combination Product (y/n): N
• PMA/PMN Number: P180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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 Operator: Lay User/Patient
• Device Expiration Date: 05/04/2022
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1