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

Model Number	1000
Medical Device Problem Codes	High impedance (1291); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that high impedance was detected on the patients device.The manufacturers device history records of the lead were reviewed.The product passed final functional and quality specifications prior to release.No further relevant information has been received to date.No known relevant surgical information has been received to date.
Event or Problem Description
It was reported that the patient underwent surgery to correct the high impedance.The pin was removed cleaned and reinserted and high impedance resolved.No further relevant information has been received to date.
Additional Manufacturer Narrative
B5.Describe event or problem, corrected data: it was inadvertently not reported on the initial mdr that pin reinsertion resolved the high impedance.Section d and h4, corrected data: the initial mdr inadvertently did not report that the generator was the suspect product section f10 and section h6, corrected data: the initial mdr inadvertently did not report in codes that the event of high impedance was due to incomplete pin insertion/surgeon error.

• Brand Name: PULSE GEN MODEL 1000
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12758695
• Report Number: 1644487-2021-01527
• Device Sequence Number: 4326174
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 12/02/2021

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: Lay User/Patient
• Device Expiration Date: 04/17/2021
• Device Model Number: 1000
• Device Lot Number: 205285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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: 58 YR
• Patient Sex: Male