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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2016
Event Type  Injury  
Event Description

It was reported by a patient¿s provider that the patient had recently fell and was having some discomfort so he went to the er. Device settings were checked and found to the same. Since the fall, the generator had migrated significantly downward. A call was received from the patient¿s caregiver also reporting that the generator had migrated to the sternum. He reported that the lead is now visible through the skin. He stated that his son has always had voice alteration with the device, but it now seems worse. He has since seen a surgeon about performing a revision surgery. It was also stated he was going to have his vocal cords checked to evaluate for any potential damage that may have occurred with the shifting of the generator and lead. Clinic notes were received from a visit to the surgeon on (b)(6) 2017 for replacement referral. The notes provide that the patient was seen at the ed for pain surrounding his vns battery. X-rays were done and labs did not reveal any sign of infection, so he was discharged home. He returned again to the ed. He did not feel his vns activate for several hours. His vns was found to be working appropriately. The battery was in an uncomfortable position for him, and was at the very superior aspect of the sternum. The skin overlying the battery and nearby lead is thin. He feels significant discomfort when lying down or on his side. He is concerned that the battery moves, but it was reported the battery has always been in this approximate position. He said it may have even been a little higher in the neck right after surgery. He has hoarseness to his voice constantly, and the patient denies any hoarseness prior to surgery. The battery is slightly mobile, but not more than expected. The skin overlying this area is thin but intact. Palpation and manipulation of the battery causes some pain. X-rays reviewed showed the vns generator overlying the superior aspect of the sternum. The lead is in an expected location. There is no evidence of fracture. It was provided the vns is in an unusual position. It was stated that the vns is functioning properly in the current location, but that it is not in the most common site for generator placement and is causing the pain. It was stated they are concerned the patient may have vocal cord paralysis from injury to the recurrent laryngeal nerve. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Manufacturer Narrative

Suspect medical device lot#, corrected data: the lot# was inadvertently not provided in the initial report.

 
Event Description

Generator replacement surgery occurred. The explant facility does not return devices to the manufacturer and the explanted device has not been received by the manufacturer to-date.

 
Event Description

Follow-up from the physician on (b)(6) 2017 provided that the patient claims ¿being back to normal¿ and does have a vns now. The patient¿s mother claims that replacement of vns fixed the problem. Diagnostics were reported to be ok.

 
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Brand NamePULSE GEN MODEL 102
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 Key6309855
Report Number1644487-2017-03160
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/10/2017
Device MODEL Number102
Device LOT Number4582
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/19/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2015
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: 02/08/2017 Patient Sequence Number: 1
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