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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 07/15/2013
Event Type  Injury  
Event Description

It was reported that the patient experienced an infection shortly after implant. The patient was given antibiotics and then the infection would subside, but would flare up again after the antibiotics were discontinued. It was reported that this was a continuous process until the surgeon felt that the generator needed to be removed to help heal the site. It was reported that the chest area had erythema on (b)(6) 2013. The patient was given a 10 day course of keflex. The patient also received two 3 day courses of keflex (one in (b)(6) after the initial 10 day course had ended and one in the beginning of (b)(6)) for dental reason. On (b)(6) 2013 the patient was seen and put on 2 weeks of keflex for left chest incision abcess. On (b)(6) 2013 the patient was seen in the office with open neck and chest incision with drainage. The physician reported that the patient's lead could be seen coming through the neck. The patient underwent explant on (b)(6) 2013. The patient was discharge on antibiotics. It was reported that the cause of the infection is unknown. No patient manipulation or trauma occurred that could have caused or contributed to the infection. Cultures were positive for staph aureus. It was reported that reimplant will occur after the patient had a few more months to heal.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 105
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 Key3425741
Report Number1644487-2013-03271
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/24/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number105
Device LOT Number3587
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/24/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2013
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: 10/23/2013 Patient Sequence Number: 1
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