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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 03/06/2013
Event Type  Injury  
Event Description

It was reported that the patient was hospitalized on (b)(6) 2012 to receive iv antibiotics due to an infection at the generator site. The patient had undergone generator replacement surgery on (b)(6) 2013. The generator was explanted on (b)(6) 2013 due to the infection. It was noted that wound cultures showed rare staphylococcus aureus and that blood cultures showed no growth for five days. The patient was discharged home on (b)(6) 2013 in stable condition on antibiotics. The patient was referred to an infectious disease physician. The surgeon plans to reimplant a new generator when the infection is cleared. It is unknown if there was any patient manipulation or trauma that occurred that could have caused or contributed to the infection. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Further follow-up revealed that the patient was swollen in the axilla and neck area and as a precaution the patient was admitted to the hospital on (b)(6) 2013 for iv antibiotics. The physician indicated that at this time there was no obvious signs of infection at the site. The patient was then readmitted to the hospital on (b)(6) 2013 with signs of infection and both generator and lead were then explanted. The physician indicated that the patient scratched at the site which could have caused or contributed to the infection.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator lead prior to distribution.

 
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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 Key3038987
Report Number1644487-2013-00929
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number102
Device LOT Number3546
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2012
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: 04/05/2013 Patient Sequence Number: 1
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