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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 08/17/2012
Event Type  Injury  
Event Description

The physician reported that there was no infection or related symptoms. Cultures were negative for infection. The patient had a "burning lesion" on the upper thoracic region "many years ago" correlated to difficult healing which compromised the skin around the vns generator. Therefore, the generator began extruding. Antibiotics were given to the patient orally. The generator and portion of the lead were explanted on (b)(6) 2013, but the lead electrodes were not explanted due to fibrosis. A replacement generator was implanted on the right side of the chest off-label. The patient's epileptic seizures have reduced significantly. The patient has responded well to the replacement surgery with no additional complaints, per the physician. Diagnostics after replacement were within normal limits. Product return is expected, but the devices have not been received by the manufacturer to date. The implant card confirmed the date of replacement of the generator and lead on (b)(6) 2013 with the reason marked as "dehiscence". Attempts for additional information have been unsuccessful to date.

 
Event Description

It was reported that the patient was being scheduled to have generator explant and to have the device replaced later in the week due to an unknown reason. Additional information was received indicating that the suture was opened, but an infection at the site was not confirmed to date. No manipulation is believed to have caused/contributed to the event. The generator and lead were both replaced. Attempts for additional information from the physician have been unsuccessful to date.

 
Event Description

Product analysis for the explanted generator and lead was completed. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Additionally, electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

The explanted generator and lead were received by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated that the reason for explant was 'dehiscense' the patient was later reimplanted. The physician reported that 'everything was told' so no additional information was provided.

 
Manufacturer Narrative

Corrected data: the initial report inadvertently did not report this data. Review of manufacturing history records performed. Review of manufacturing history records of the generator and lead confirmed sterilization and all quality tests passed 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 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 Key3021530
Report Number1644487-2013-00815
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/28/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2013
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 Number2967
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/17/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/12/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/21/2011
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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