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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 05/23/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 were received. The patient came in for a follow up for the vns implant which occurred on (b)(6) 2013. The notes state that the patient attends today with plication of a small amount of the skin at both incisions which was necrotic and sloughed off. Now these areas are wider. The subcutaneous tissues are clearly exposed. The physician states that he did not see any evidence of the device. The physician exam found no evidence of surrounding infection. The skin is healthy and clean. The neck incision looks well healed. Per the notes, the surgeon states that the best thing to do is to take the patient back to the operating room and reclose the skin, as this would hopefully prevent infection, particularly in view of the patient's past history of infection (the patient's first vns was "lost due to infection" of (b)(6) - previously reported in manufacturer report #: 1644487-2012-00700). Clinic notes dated (b)(6) 2013 indicate that post vns insertion is complicated by infection removal. The vns placement was done okay, apart from the chest incision, where the skin has dehiscenced slightly. A physician exam indicates the incision on the chest dehiscenced in two places. Operative notes from (b)(6) 2013, indicate the patient's generator was explanted. When the chest incision was opened, there was a large amount of pus in the pocket around the generator. This was all evacuated and sent for culture and sensitivity. The neck incision was opened and pus was seen to be around the lead. The three electrodes were individually removed with the lead in its entirety. The lead and generator were both completely removed. Pulse irrigation was then used on both the neck and chest incisions to significantly clean this out and half inch gauze was then placed into the incisions. The patient was seen on (b)(6) 2013 and her incisions were treated with dressing changes. A physician exam indicated that her incisions were open, but red and granulating. The notes indicate that the isolated organism is staphylococcus aureus, which is sensitive to cipro and clindamycin i. The physician gave the patient this for 21 days in addition to further hydrocodone for pain. Notes dated (b)(6) 2013, found that the patient said she was unable to take the clindamycin and was not able to afford the cipro. Per the notes, the patient now has enough money to start the cipro again and has no new problems. Per a physical exam, the neck incision was well healed and the chest incision is still open but is granulating. There is no evidence of infection. The plan at this juncture, per the notes, is that the patient should restart cipro and would be seen in three months. The device manufacturing records for both the generator and lead were reviewed. Sterilization was confirmed. The patient's last programmed settings from (b)(6) 2013 was found in the manufacturer's internal programming history database.

 
Manufacturer Narrative

Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

 
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Brand NamePULSE GEN MODEL 103
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 Key3292619
Report Number1644487-2013-02439
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number103
Device LOT Number202372
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2013
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: 08/16/2013 Patient Sequence Number: 1
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