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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 (1395); Unexpected Therapeutic Results (1631)
Patient Problems Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271)
Event Date 08/21/2014
Event Type  malfunction  
Event Description
A nurse at the treating physician's office reported that the reason for the magnet stimulation not perceived was due to the patient not swiping the magnet over the generator area.Once they were able to locate the generator, the patient was able to feel magnet stimulation.There was no report of normal mode stimulation not perceived.The generator was located more medially and lower than the patient and staff thought.The patient has a lot of soft tissue and is of large stature.The nurse was unable to provide additional information on the increased seizures.No interventions were reported.The patient has been doing well.
 
Event Description
Additional information was received stating that vns patient¿s issues had resolved.Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures, was unable to perceive stimulation, had pain at the electrode site, and had a ¿hard mass¿ in the generator pocket.Follow-up revealed that the patient¿s generator was tested and diagnostic results showed normal device function.No trauma was reported to have occurred.The patient¿s device reportedly had migrated south but was not causing any harm to the patient.The patient had her magnet taped over her device to improve her voice hoarseness and gagging; however, the pain in the patient¿s neck did not resolve.X-rays dated were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The patient¿s magnet was taped over the generator so an assessment cannot be made in regards to the filter feed-through wires and the lead connector pin.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
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Brand Name
PULSE GEN MODEL 103
Type of Device
GENERATOR
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 Key4101231
MDR Text Key5302762
Report Number1644487-2014-02386
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 08/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/31/2012
Device Model Number103
Device Lot Number201679
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 01/07/2015
Initial Date FDA Received09/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/11/2014
01/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
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