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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 04/22/2016
Event Type  Injury  
Event Description

On (b)(6) 2016, patient mentioned that she thinks the generator is drifting more laterally on her chest wall. X-rays were taken and was reported to be intact per the physician. Further attempts to learn whether non-absorbable suture was used to secure the generator in place on (b)(6) 2012 were made but were unsuccessful to date. Clinic notes were received for patient's referral for prophylactic generator replacement with the intention of addressing the generator migration at that time. Clinic notes stated that the patient's generator is dislodged from the pocket and is projecting through the skin in the armpit. The patient was referred for surgery to reseat the generator in the pocket. The device was checked and was confirmed to be working fine. The settings were increased as patient feels that she is experiencing breakthrough auras and seizures. Patient underwent prophylactic generator replacement on (b)(6) 2016. The explanted generator will not be returned to manufacturer by the hospital. Additional relevant information has not been received to date.

 
Event Description

Additional information was received that the patient did experience an increase in seizures and auras but its below pre-vns baseline and is not believed to be related to vns. This will not be captured/coded as a result. The physician is uncertain on the cause of device migration.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5853731
Report Number1644487-2016-01778
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2013
Device MODEL Number103
Device LOT Number201734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2011
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: 08/08/2016 Patient Sequence Number: 1
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