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

Model Number 1000

Device Problems Energy Output Problem (1431); Premature End-of-Life Indicator (1480)

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

Event Date 07/09/2020

Event Type  malfunction  

Event Description

It was reported that patient was having a battery replacement due to battery depletion.Prior to implanting the new generator, diagnostics was performed outside the pocket showing the device was functioning as expected.After the generator was implanted, the device was interrogated and "error code 14, current unavailable" was displayed.After heartbeat detection was verified to confirm the feature was working properly and the session was ended, the device was re-interrogated and diagnostics were performed with no further issues were observed.No additional relevant information has been received to date.

Event Description

Through further review of the data it is believed that an asic latch up scenario did not occur for the generator as voltage readings were normal and there was no indication of a drop.It was noted that there was possible transient event that caused noise in the internal supply lines.The data reviewed showed that the device reset occurred about 40 seconds after the completion of the last "good" diagnostics.No additional relevant information has been received to date.

Event Description

It was reported by sales representative that during the generator replacement, electrocautery was not used once the new generator was brought into the sterile field.It was determined that error code 14 is related to a brown out reset, which occurs when the battery voltage suddenly drops and is not able to supply current.This is known event that can occur when the device is struck by a strong electrical current from either electrocautery/electrical devices or from electrostatic discharge.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10144813
• MDR Text Key: 194944925
• Report Number: 1644487-2020-00801
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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: 03/31/2022
• Device Model Number: 1000
• Device Lot Number: 205270
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 07/09/2020
• Supplement Dates FDA Received: 07/08/2020; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR