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U.S. Department of Health and Human Services

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

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem High impedance
Event Date 01/21/2019
Event Type  Malfunction  
Event Description

It was reported that high impedance was observed on the patient's m1000 generator. It was stated that on approximately two weeks after the date of implant, the impedance was within normal limits. At the end of that month, the impedance value was within normal limits but approaching the high impedance threshold. Diagnostics performed at the next office visits fluctuated between high impedance and within normal limits remaining near the high impedance threshold. It was stated that the patient is a physically large person and has a right side implant due to a pacemaker on his left side. The leads have to travel "quite a distance" to get to the vagal nerve. No adverse events associated with this high impedance were reported. It was later reported by the company representative that the physician felt the lead was too short as the lead was pulling and was visible across the patient's neck. The patient was referred to the implanting surgeon for evaluation of the lead and high impedance. A review of device history records revealed that the generator passed quality control inspection prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. 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. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 1000
Type of DeviceGENERATOR
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 Key8375426
Report Number1644487-2018-02922
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 04/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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