MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was approved for a returned generator.During the analysis it was identified that the generator yielded erratic results for the battery voltage calculation, as the voltage measurement was calculated as 2.153 v, but the measurement of the generator with the case removed was 2.894 v.The microprocessor signals observed from this device were approximately the same as those observed from a bench device.The failure mechanism for the battery voltage calculation error was not ascertained, but the microprocessor is the suspected component as it performs the calculations.There were no additional performance or any other type of adverse conditions found with the pulse generator.No additional relevant information has been received to date.

Event Description

Troubleshooting activities were performed in product analysis to determine the root cause of the reported adverse event for the generator; however, the cause of this event has not been determined to date.Of the possible root causes identified, all but faulty operation of the microcontroller¿s analog to digital operation has been eliminated.Further investigation into this issue led to the most likely conclusion that the faulty analog to digital conversion in the microcontroller was caused by random component failure.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 7478488
• MDR Text Key: 107199286
• Report Number: 1644487-2018-00708
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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: 01/05/2017
• Device Model Number: 105
• Device Lot Number: 4219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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