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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/27/2012
Event Type  Malfunction  
Event Description

Reporter indicated a patient developed a wound infection at the vns generator site pocket in the chest on approximately (b)(6) 2012. The patient had been recently implanted with the generator on (b)(6) 2012. The wound was noted to be open on (b)(6) 2012. The vns lead was visible at the height of the left breast. The vns generator was performing as intended and working properly. Oral antibiotics were given, and the patient had wound debridement and irrigation surgery performed with high-pressure iodum solution. Antibiotics are to continue. The cause of the infection may be due to the recent implant surgery, but the patient may have also had trauma/device manipulation that may have contributed to the infection.

 
Event Description

The return product form indicates the generator was explanted due to "vbat < eos threshold". Product analysis was performed on the returned generator. The premature eol (end of life) was duplicated in the product analysis lab. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccum consumed memory locations revealed that 6. 035% of the battery had been consumed. No additional information has been provided.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution. The lead information is currently unknown; as such a review of the lead manufacturing records is not possible.

 
Manufacturer Narrative

End of service message seen upon interrogation of the pulse generator.

 
Event Description

Reporter indicated the vns lead was removed due to infection on (b)(6) 2013, but the generator remained in the patient. The patient was implanted with a new generator and lead on (b)(6) 2013. The generator was replaced as it was felt it had been damaged by electrocautery use during the (b)(6) 2013 lead removal surgery. The explanted generator was returned on (b)(4) 2013 and is pending analysis. The explanted lead was not returned.

 
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Brand NamePULSE GEN MODEL 103
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 Key2899542
Report Number1644487-2013-00071
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number103
Device LOT Number202144
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/25/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2012
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: 01/07/2013 Patient Sequence Number: 1
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