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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 08/03/2012
Event Type  Injury  
Event Description

Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On (b)(6) 2012, it was reported that the patient had a skin breakdown at the left generator site. The patient presented to the emergency room, and underwent generator revision. On (b)(6) 2012, additional information was received confirming that the patient underwent generator revision on (b)(6) 2012. The patient presented to the emergency room with skin breakdown over the left chest with exposure of the generator. It appeared that an infection may have been starting, but no information was available regarding if cultures were taken to confirm an infection. It was also unknown if the seroma was verified. The patient was reportedly developmentally delayed; therefore, it was unclear if the patient was messing with the incision site or if another event preceded the event. The patient was on iv antibiotics after revision. The patient was seen on (b)(6) 2012 and was said to be doing well at that time.

 
Event Description

On (b)(6) 2012, it was reported that there was fluid around a patient's device, that the incision site had opened, and that fluid was draining. On (b)(6) 2012, an implant card was received indicating that this patient underwent generator revision on (b)(6) 2012 due to an adverse event of 'protruding through skin. ' attempts for additional information will be made.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Event description, corrected data: previously submitted mdr inadvertently omitted text stating that the generator and lead were confirmed to have been sterilized prior to distribution. This report is being sent to correct this information.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2722493
Report Number1644487-2012-02195
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number105
Device LOT Number202144
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/21/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2012
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: 08/31/2012 Patient Sequence Number: 1
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