MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 8103; GENERATOR

Model Number 8103

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that a patient has a device deficiency noted as the magnet not inhibiting stimulation.The device was explanted and returned for analysis.Product analysis was approved.The pulse generator was unable to be interrogated as received, so it was converted from a m8103 to a m103, and interrogation was successful.This conversation enabled magnet current functions that are unavailable with m8103 devices.However, when a magnet was applied to the generator at distances of 1.25 and 0 inches, magnet current would not activate.The reed switch was found to be stuck open.The voltage measured at the reed switch before closure was approximately 1.55 volts.When the magnet was applied to close the reed switch, the voltage was approximately 0.23 volts.After multiple reed switch closures, the reed switch became functional.The failure mechanism for the as-received condition with the non-closure of the reed switch was not determined.Device history records were reviewed for the generator which passed all specifications and had no non-conformances prior to distribution.

• Brand Name: PULSE GEN MODEL 8103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15893856
• MDR Text Key: 307892784
• Report Number: 1644487-2022-01533
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

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 Operator: Lay User/Patient
• Device Expiration Date: 01/28/2022
• Device Model Number: 8103
• Device Lot Number: 205219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female