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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 06/26/2016
Event Type  Injury  
Event Description

It was reported that vns patient underwent a generator replacement. The reason mentioned on the implant card was "patient cut the incision". The lead impedance was ok after the replacement. The explanted generator was implanted on (b)(6) 2016. Further follow up indicated that the patient (mentally delayed) was implanted with the vns therapy since 2010 with positive outcome. He was admitted to the general hospital in the remote region on (b)(6) 2016, where they looked over the incision, they cleaned the wound, and stick dressing on the wound. While visiting the vns clinic as regular procedure to ramp up the device on (b)(6) 2016, they looked over the incision and found out the wound was open (patient was trying to remove out the device). The patient was admitted directly to the or for the next day on (b)(6) 2016 to clean and seal the wound. The neurosurgeon decided to replace the generator prophylactically; he cleaned the wound and changed the position of the generator in order not to have any infection. No explanted device is available to be returned to the manufacturer for analysis. The review of the manufacturing records confirmed the sterilization with (hp method) for the generator prior to the distribution.

 
Event Description

The review of the manufacturing records confirmed the sterilization with (hp method) for the lead prior to the distribution. Further follow up indicated that the lead was not replaced.

 
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Brand NamePULSE GEN MODEL 106
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 Key5942292
Report Number1644487-2016-02027
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/10/2016
Device MODEL Number106
Device LOT Number203083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/12/2014
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: 09/12/2016 Patient Sequence Number: 1
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