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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/30/2012
Event Type  Injury  
Event Description

A surgeon's office reported that a vns patient was seen on (b)(6) 2013 and it was observed that their generator incision site was oozing and open. The patient was referred for a battery replacement and wound exploration, and antibiotics were prescribed. The patient has an ongoing issue with needing to have pocket revision surgery. A clinic note was received dated (b)(6) 2013. In her history it reports that the patient's generator had migrated into their breast tissue this was repositioned. Addressed in medwatch number: 1644487-2011-01242. Currently she is experiencing irritation and possible granulation/inflammation lower in the chest and in the breast with induration. Their device was interrogated and showed roughly 40-50% on the battery. The patient had their generator replaced on (b)(6) 2013. It has been returned for analysis but not completed at this time. Previously the patient went to surgery on (b)(6) 2012 for left chest wound exploration. The patient had a granulating wound of the left chest. The patient's granulation tissue was removed and immediately revealed the wires that were immediately under the skin. Another pocket was created and the generator and wires moved into it. She did well and was discharged.

 
Event Description

The generator was returned due to low battery and demipulse eos status unknown. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the lab. The battery is partially depleted, 2. 795 volts, at ifi, as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 104. 245% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

The patient was seen for followup on (b)(6) 2013. They continue to have migration and dehiscence issues with their new generator that was implanted (b)(6) 2013 addressed in medwatch report number: 1644487-2013-01211.

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr) - corrected data; supplemental 01 sent with incorrect date of (b)(4) 2013 and it should have been (b)(4) 2013.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 Key2993042
Report Number1644487-2013-00626
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/15/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2013
Device MODEL Number103
Device LOT Number201721
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/01/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/25/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/30/2011
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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