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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
Device Problems Migration or Expulsion of Device ; Adverse Event Without Identified Device or Use Problem
Event Date 12/04/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table. The patient reported that her generator migrated up towards her collarbone. The company representative saw that the generator was in a position that is commonly placed by surgeons. The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck. Diagnostics were performed, which were within normal limits. X-rays were performed, and they showed that the generator was situated near the left armpit of the patient. The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators. The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays. The location of the bruise is where the patient claimed that the generator was prior to the fall. The patient was referred for revision surgery to ensure the correct placement of the generator. No surgical intervention has occurred to date. Attempts for further information were unsuccessful to date.

 
Event Description

The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall. Pocket revision surgery was planned due to the migration of the generator. However, the patient saw her neurologist again instead of going to see the surgeon. The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

 
Event Description

Clinic notes were received for the patient's appointment with the physician. The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm. The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months. The patient also could feel the generator moving towards the axilla. The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration. The physician referred the patient for surgery to get a new generator and fix the migration. No surgical intervention has occurred to date.

 
Event Description

The patient had generator replacement surgery due to migration/pain. The device was explanted by the hospital. Therefore, no analysis could be performed.

 
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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 Key5337448
Report Number1644487-2015-06871
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 04/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/15/2014
Device MODEL Number103
Device LOT Number202298
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2012
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: 12/30/2015 Patient Sequence Number: 1
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