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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/08/2019
Event Type  Injury  
Event Description

It was reported that the patient was referred for explant as the device was unable to be interrogated and the patient was having pain in the left side of their chest at the generator site. The patient was not getting a replacement as they were doing well on their current medications. Programming history was reviewed for the patient and no anomalies were seen. An automatic battery life calculation for the patient found that there was 0. 0 years until near end of service. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key8583709
Report Number1644487-2019-00866
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Type of Report Initial
Report Date 05/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/26/2004
Device MODEL Number102
Device LOT Number7732
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/28/2003
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: 05/06/2019 Patient Sequence Number: 1
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