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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/01/2013
Event Type  Injury  
Event Description

It was reported that the patient experienced inflammation around the generator pocket approximately 6 months after implant. It was reported that the patient informed the physician that she had swelling and pain over the generator site, but denies redness or heat. The patient reported that the swelling had been present for 4-5 days. The patient was seen by the physician on (b)(6) 2013 at which time the generator site was found to have a "boggy"; swelling over it, but no redness. It was reported that the patient reported discomfort and that there was some skin discoloration. The fluid was aspirated and found to be pus. The patient underwent generator and lead explant; however, the exact date of explant is unknown. The pocket was irrigated and the patient was placed on iv antibiotics. It was reported that treatment is ongoing. It was reported that the swelling and infection was localized to the site of the generator and that the wounds from the vns implant were fully healed. The patient denies trauma or manipulation which may have caused or contributed to the infection. Cultures showed isolated staphylococcus aureus. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

It was reported that the generator and lead were to be returned for analysis. The generator and a piece of the lead were returned to manufacturer for analysis on (b)(6) 2013. Analysis of the lead was completed on (b)(6) 2013. Note that since a significant portion of the lead (including the electrode) portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(6) 2013. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation.

 
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 102
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 Key3339646
Report Number1644487-2013-02645
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2014
Device MODEL Number102
Device LOT Number202188
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/21/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2012
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: 09/10/2013 Patient Sequence Number: 1
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