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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 03/12/2013
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that this vns patient required a lead revision for an unknown reason. Follow-up showed that the surgery was for repositioning of the lead. During surgery on (b)(6) 2013, the patient's generator was in the axillary position and moved to chest area. It is unknown where in the chest the device was initially implanted. Attempts for additional information have been unsuccessful.

 
Event Description

Additional information was received indicting that the patient was referred for surgery due to pain/pinching in her axillary area. It is unknown exactly when this began. The surgery was for patient comfort. No patient manipulation or trauma occurred that is believed to have caused/contributed to the event. A non-absorbable suture was not used to secure the generator to fascia during implantation of the generator.

 
Manufacturer Narrative

 
Manufacturer Narrative

Corrected data: previously submitted mdr indicated the patient was the operator of the device. Additional information was received indicating that the physician may have contributed to the error. This report is being submitted to correct this data.

 
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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 Key3043572
Report Number1644487-2013-00827
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/18/2014
Device MODEL Number103
Device LOT Number202041
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2012
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: 04/09/2013 Patient Sequence Number: 1
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