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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/01/2013
Event Type  Injury  
Event Description

It was reported that the patient's vns device was removed on (b)(6) 2013. Attempts were made for additional information and product return; however, they were unsuccessful.

 
Event Description

It was reported that the explanted generator was discarded by the hospital. Therefore, analysis cannot be performed.

 
Event Description

The surgeon's office reported that it was unknown if a non-absorbable suture was used to secure the generator to the fascia during implant surgery as it was not in records.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report reported the age incorrectly.

 
Event Description

On (b)(6) 2013 it was reported that the patient saw another neurologist and it was determined that she does not have epilepsy so she wants the vns removed.

 
Event Description

On (b)(6) 2013 it was reported that the patient was referred for generator replacement due to "discomfort and movement". It was previously reported that the patient's vns was at end of service; but diagnostics later confirmed that the device was not at end of service. It was later clarified that the "movement" was migration of the vns generator. Clinic notes were received dated (b)(6) 2013 that state the patient is awaiting prophylactic surgery for her generator to be replaced due to discomfort and movement. The patient has a medical history of copd and went to the e. R. With difficulty breathing during a seizure on (b)(6) 2012 and to the e. R. On (b)(6) 2013. The clinic notes dated (b)(6) 2013 indicate that the patient states her magnet mode stays on after a magnet swipe and she has to hold the magnet over the generator for a few minutes so that it will go back. It was later reported that the patient first noticed the device started moving around a couple of months ago after being admitted to the hospital for west nile virus. A cat scan had been performed at that time. The patient also started experiencing a burning pain at the generator which goes up to the neck that occurred with stimulation. The patient also mentioned that the magnet stimulation is particularly painful, and mentioned that when the device is swiped, it will stay on at the magnet settings until she holds the magnet over it to disable the stimulation. The patient said, after doing so and removing the magnet, it will go back to the normal generator settings. The patient says they have tried to make changes to the parameter settings to lessen the painful stimulation but there has been no improvement. The patient said she discussed this with the implanting physician who told her the device "is probably messed up". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not yet occurred.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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 Key3025829
Report Number1644487-2013-00849
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number102
Device LOT Number3233
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2012
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: 03/28/2013 Patient Sequence Number: 1
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