MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems Computer Software Problem (1112); High impedance (1291)

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

Event Date 08/17/2018

Event Type  malfunction  

Event Description

High impedance was identified during a periodic review of the manufacturer's programming history performed by the manufacturer.The high impedance value was 5356 ohms which is just above the 5300 high impedance lower limit threshold.At the next available appointment in the data at the time of this report shows that the impedance resolved to 4681 ohms.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators.As indicated in the physician's manual, high lead impedance (>/=5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction this event is consistent with this investigation.The generator's manufacturer's device history records was reviewed.The generator passed final functional and quality specifications prior to release.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10814691
• MDR Text Key: 215515344
• Report Number: 1644487-2020-01498
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2020
• Device Model Number: 1000
• Device Lot Number: 204455
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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: 48 YR