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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 07/19/2013
Event Type  Injury  
Event Description

Additional follow up with the neurologist's office confirmed that the patient has still not reported the events to the office.

 
Event Description

The patient reported via (b)(6) that she had surgery seven days prior to replace her vns generator was still hurting. The patient later contacted the manufacturer and reported that the top of her incision appeared to be slightly opened. The surgeon was contacted; however, he stated that they had not seen the patient since surgery. On (b)(6) 2013, the patient reported that she was okay and was not complaining about pain or the device. She stated that she was in pain on the day of surgery for a while when the device was programmed, but now that she has healed more the stimulation is not as painful. The patient stated that the incision scar is still pretty painful when she does a lot of stretching of her arm, but that she knew this was part of the healing process from having surgery. Otherwise, the patient said she was fine and did not need to see her physician and only went on an emergency basis. The patient again clarified that she felt she was okay in the healing process and was not having issues with the device itself. Follow up with the physician's office indicated that the patient has not been seen since her pre-op visit. Follow up with the patient's other physician indicated that she was seen on the morning post-op the day after replacement surgery and has not been heard from since. It was stated that the patient has not reported any problems or complaints, so they were unaware of any issues. The patient's device was programmed on to previous settings at the post-op visit. No additional information has been provided.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 105
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 Key3330872
Report Number1644487-2013-02611
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number105
Device LOT Number3620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/09/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/08/2013
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: 09/06/2013 Patient Sequence Number: 1
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