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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 02/25/2014
Event Type  Injury  
Event Description

The patent had generator pocket revision on (b)(6) 2015. The surgeon moved the generator from the armpit area and into the front chest area below the collarbone. While moving locations, he decided to replace the generator in the process due to the patient's complaint of shocking sensations. The explanted generator was discarded. Therefore, analysis is unable to be performed.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.

 
Event Description

Initially, it was reported that the patient was experiencing a shocking sensation with device stimulation following generator replacement. It was reported that device diagnostics were within normal limits. The physician indicated that the patient may be referred for lead replacement. It was later reported that the patient was referred for generator and lead replacement at the patient's request. No additional relevant information has been received to date. Surgery is planned, but has not occurred to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 104
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 Key4441302
Report Number1644487-2015-03680
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/31/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number104
Device LOT Number3688
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/30/2013
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: 01/22/2015 Patient Sequence Number: 1
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