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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 09/27/2011
Event Type  Injury  
Event Description

Vns generator product information was obtained from the implanting hospital.

 
Event Description

Reporter indicated there "is nothing wrong with my vns" and that the issue of pain was felt to be related to medication and not vns. The vns is felt to be "working well" per the reporter, but she has no physician to check the vns. All attempts to obtain vns generator product information from the implanting hospital have been unsuccessful to date.

 
Event Description

The patient reported that she is ok, but that she no longer has transportation to her physician and is searching for a new physician. No additional relevant information has been obtained to date.

 
Event Description

A vns patient reported to the manufacturer on (b)(6) 2011 that she was experiencing pain "all over" and sometimes in her head and neck. The patient was attributing the pain to vns. The patient did go to the emergency room and was treated with anti-inflammatory medication. The patient is under a great deal of personal stress. The patient was advised to follow up with her physicians, but the physicians would not see the patient. The patient later reported to the manufacturer on (b)(6) 2011 that she was attributing her pain to a fall or her medications or possibly an ulcer. The patient is to follow up with a nurse practitioner in (b)(6) 2011. Attempts to the nurse practitioner for further information are pending.

 
Event Description

The patient reported that her settings were lowered by half and the next day she was experiencing pain. She went to the emergency room the day prior and was sent home. The patient noted that her whole body is sore and that she walked a lot yesterday.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 Key2309512
Report Number1644487-2011-02586
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2012
Device MODEL Number103
Device LOT Number2749
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/09/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/11/2010
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: 10/26/2011 Patient Sequence Number: 1
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