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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/01/2010
Event Type  Injury  
Event Description

It was reported that the pt's generator had migrated into her armpit which made wearing a bra painful sometimes. Pt also reported some pain under her collarbone, but it is unk whether this is occurring with stimulation or not. The pt is handicapped and cannot describe the pain very well. The migration did not occur near the time of implant at all. The pt experiences many bad falls associated with her seizures which the pt's family feels caused the generator migration. It was also reported that the pt will likely have surgery to address the migration at which time they will likely replace the generator prophylactically. Pt is "surgery shy", however, and is waiting to discuss with family whether to undergo surgery. X-rays were taken of the pt's device and sent to mfr for review. Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1689573
Report Number1644487-2010-01138
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2005
Device MODEL Number102
Device LOT Number9813
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/12/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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: 05/12/2010 Patient Sequence Number: 1
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