MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000-D; GENERATOR

Model Number	1000-D
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that generator intended to be implanted in the patient was unable to be interrogated.Troubleshooting was attempted, efforts were made to reduce emi, however the generator was still unable to be interrogated after several attempts.The surgeon opted to implant a different generator which was implanted and successfully interrogated.Device history records were reviewed and the device was seen to pass all functional and quality testing prior to distribution.The device has been received into product analysis.No other relevant information has been received to date.
Additional Manufacturer Narrative
H6 investigation findings; corrected data; initial mdr inadvertently entered incorrect code.
Event or Problem Description
Product analysis was completed and it was discovered that the device was likely exposed to electrocautery causing a premature depletion of the battery.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000-D
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 19004338
• Report Number: 1644487-2024-00360
• Device Sequence Number: 9457387
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: 1000-D
• Device Lot Number: 853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/23/2023; 05/13/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male