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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 10/07/2003
Event Type  Injury  
Event Description

Initially, it was reported that the patient was scheduled for vns replacement surgery. The reason was not provided. It was later reported that the patient underwent a vns system implant because the device had been removed previously due to a (b)(6) infection. Further follow-up revealed that the patient underwent explant in 2004 due to the infection. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

It was reported that the patient was hospitalized on (b)(6) 2003. The patient underwent generator explant on (b)(6) 2003 and the patient was discharge from the hospital on (b)(6) 2003. The patient had been hospitalized for systemic sepsis and had a multitude of comorbidities including lung inflammation, pulmonary embolism, boils, acute respiratory failure, heart infection and renal failure. It was reported that the patient was in prison when the patient contracted the illness and the nurse attributed the cause of the sepsis and resulting comorbidities to the unclean prison environment. There was no known trauma or manipulation. The nurse did not believe that vns was related to the infection. The device was explanted prophylactically. The physician believed that having the generator explanted would improve the patient's ability to heal.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

New information corrects the date of event and date of explant reported in initial mfr. Report.

 
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Brand NamePULSE GEN MODEL 101
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3676801
Report Number1644487-2014-00678
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/09/2002
Device MODEL Number101
Device LOT Number3248
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/26/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2001
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: 03/13/2014 Patient Sequence Number: 1
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