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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/28/2011
Event Type  Injury  
Event Description

It was reported that the pt was experiencing painful and erratic stimulation in the neck. Pt says pain is at the generator site and up the lead to the neck, and is erratic and not just with stimulation. The physician programmed the pt's device off and took x-rays of the device. X-rays were not sent to the mfr for review. The physician feels that the generator has moved because he could not feel it in the past and can now clearly palpate the generator. Later info reveals that the generator had slipped into the armpit area. No trauma or manipulation has occurred. The pt was also experiencing an increase in seizures after the device was turned off due to loss of therapy. The pt underwent surgery to revise the generator pocket and secure the generator down. Diagnostics were all normal. The lead was also revised during surgery due to fluid being seen in the tubing (addressed in medwatch # 1644487-2011-01083). Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2096033
Report Number1644487-2011-01082
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/09/2012
Device MODEL Number103
Device LOT Number2779
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/14/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
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: 05/13/2011 Patient Sequence Number: 1
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