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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 06/05/2014
Event Type  Injury  
Event Description

It was reported that the vns patient¿s generator had migrated toward the anterior axillary line. The patient had been experiencing some pain at her generator site. The patient did not have any fever, abrasions, or discoloration; however, the patient felt her generator was protruding into her armpit. The generator incision had healed well and the device was still functioning as expected. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

On (b)(6) 2014 it was reported that the patient had pocket revision surgery to correct the pain in july 2014 but that the pain started again recently. Now the patient is experiencing a headache, chest pain, and pain on the left side of the neck. The patient was referred for x-rays. The patient saw the neurologist on (b)(6) 2014 complaining of pain and per the neurologist, the lead is protruding in the armpit area. The neurologist did not have a programmer to turn off the vns. The neurologist referred the patient for surgery as the patient wants the vns removed. Although surgery is likely, it has not occurred to date. On (b)(6) 2014 it was reported that the physician had the vns turned off due to the patient¿s complaints of pain radiating up her neck, migraines, and pain at the generator site. The settings prior to being disabled were noted to be current output: 0. 25ma/frequency: 15hz/pulse width: 250usec/time on: 30 sec/time off: 1. 1 min/magnet output: 0. 50ma/mag time on: 60 sec/mag pw: 500usec. System diagnostics test was performed which showed lead impedance: ok/impedance value: 3647ohms/ifi: no. Attempts were made for further information but were unsuccessful.

 
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Brand NamePULSE GEN MODEL 103
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 Key3906342
Report Number1644487-2014-01647
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number103
Device LOT Number3540
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/25/2013
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: 07/01/2014 Patient Sequence Number: 1
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