MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number	102R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion, Clonic (2222)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is having an increase in seizures and mother believes it to be related to battery depletion.Battery was checked and impedance was noted to be ok and battery ok.No known surgery has occurred to date.No additional relevant information has been received to date.
Event or Problem Description
Implant card was received noting that the patient had a prophy battery replacement.It was reported that when the orss checked the battery prior to surgery it was found that the patient¿s settings were reset.There were multiple communication issues performing diagnostics but interrogation was fine.All communication troubleshooting steps were attempted but did not work at first and with the interrupted diagnostics it had reset the generator settings several times.Orss was finally able to get the diagnostics to go through and impedance was fine.It is unknown how long ago the device was set to factory settings but there was records from the patient¿s last visit with physician showing device had been on.Explanted generator was sent back to pathology after being replaced.Information was also received that the increase in seizures was suspected to be due to the low battery.No explanted product has been received to date.No additional relevant information has been received to date.
Additional Manufacturer Narrative
F7.Type of report ¿ correction ¿ inadvertently did not mark follow-up and put 01 for supplemental mdr #01 submitted.

• Brand Name: PULSE GEN MODEL 102R
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11998744
• Report Number: 1644487-2021-00818
• Device Sequence Number: 3560361
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/12/2018
• Device Model Number: 102R
• Device Lot Number: 203828
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/10/2021; 10/01/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/01/2021; 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR