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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
Device Problem Insufficient Information
Event Date 06/16/2014
Event Type  Injury  
Event Description

It was reported that the vns study patient developed an infection on (b)(6) 2014 at the incision site. Furthermore, the patient¿s incision site reportedly had opened. The infection was attributed to the vns implant surgery. The patient was hospitalized from (b)(6) 2014. The patient underwent surgery on (b)(6) 2014 to explant the generator and lead.

 
Manufacturer Narrative

 
Manufacturer Narrative

Pt age at time of event: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth for the patient. Pt gender: the previously submitted mdr inadvertently provided an incorrect sex for the patient. Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event.

 
Event Description

Further information indicated that the event ended on (b)(6) 2014. The patient recovered. Review of manufacturing records confirmed sterilization for the generator 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
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 Key3987355
Report Number1644487-2014-01961
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device MODEL Number102
Device LOT Number202614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/14/2013
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: 08/07/2014 Patient Sequence Number: 1
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