MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Output Problem (3005)

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

Event Date 01/23/2020

Event Type  malfunction  

Event Description

It was reported that during a planned prophylactic generator replacement turned lead revision due to lead fracture (as reported in mfr report # 1644487-2020-00286), output current on the generator was unexpectedly 0 ma.Preoperatively, settings and diagnostics were within normal limits; however, when the attending representative tested the device after the lead fracture was observed the impedance was okay and the output current was 0 ma.No settings were changed.However, it is believed possible that diagnostics weren't run, given that the impedance value didn't change after a complete lead break was observed.Reportedly, no electrosurgical tools were used during the procedure.The explanted generator was discarded.No further relevant information has been received to date.

Event Description

Data review determined that the reported output current changing to 0 ma was a low output current caused by the lead fracture (determined to be due to user error) reported in mfr report # 1644487-2020-00286.This is an expected event and not indicative of device failure.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9727302
• MDR Text Key: 184652023
• Report Number: 1644487-2020-00287
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

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: 08/06/2017
• Device Model Number: 103
• Device Lot Number: 300364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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: 56 YR