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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/19/2012
Event Type  Injury  
Event Description

A fax was received on (b)(6) 2012, from the patient's physician. The fax indicated that additional interventions included "cardiology consult and simultaneous". The patient did not have a previous history or family history of cardiac events. The patient's pre-existing conditions included neonatal cerebral abscesses, infantile spasms, intractable epilepsy, and global developmental delay. The patient experienced bradycardia. Prior to the event, the patient's heart rate was 109 bpm. During the event, the patient's heart rate was 104 bpm.

 
Event Description

On (b)(6) 2012, it was reported that this vns patient experienced an arrhythmia during initial implant surgery that day. The patient was successfully implanted. An in-pocket system diagnostic was normal, and a final interrogation confirmed that the normal mode and magnet mode output currents were 0. 00 ma. During the first system diagnostic test, the surgeon noticed a heart arrhythmia during the vns stimulation period. He stated it was not bradycardia, just an abnormal arrhythmia. The system diagnostic test was repeated multiple times, all tests were within normal limits, and the arrhythmia was still present. Following each test, the surgeon attempted to re-position the coils on the nerve to maximize the distance between the coils and the cervical branch of the vagus nerve. He stated the arrhythmia was minimized but was still present after the repositioning of the coils. He stated this was likely due to the very small size of the patient and the short length of nerve he had to work. Attempts for additional information have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2792641
Report Number1644487-2012-02632
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/30/2013
Device MODEL Number102
Device LOT Number201936
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/16/2012 Patient Sequence Number: 1
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