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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 08/04/2014
Event Type  Injury  
Event Description

The physician reported that the patient has an infection at the generator pocket since recent generator replacement. It was reported that there is fluid around the pocket and is swollen with an increased white blood cell count and fever. The physician also believes the infection has traveled to the lead at the clavicle area. The physician is considering explanting the generator and a portion of the lead as far up as can be reached without opening the neck incision. Once the infection is healed the patient will undergo reimplant. No additional information has been received to date.

 
Event Description

Additional information was received stating that the vns patient underwent surgery to explant her device due to infection. The patient was later re-implanted with a new generator and lead on (b)(6) 2014. Review of manufacturing records confirmed sterilization for both the explanted generator and lead prior to distribution.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 105
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 Key4085399
Report Number1644487-2014-02331
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2016
Device MODEL Number105
Device LOT Number202951
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2014
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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