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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin. The patient mentioned that her device had been like this for two years. The patient's generator later migrated to her armpit and was causing her pain. No further relevant information has occurred to date. No surgical intervention has occurred to date.

 
Manufacturer Narrative

Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.

 
Event Description

The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to. The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration. The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator. As such, the physician believed that the generator must have fallen down on its own. The physician planned to resolve the protrusion and migration during replacement surgery. The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort. No further relevant information has occurred to date. No surgical intervention has occurred to date.

 
Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

The patient underwent full revision surgery. The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key6452971
Report Number1644487-2017-03543
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2008
Device MODEL Number102R
Device LOT Number015168
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/08/2006
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: 04/03/2017 Patient Sequence Number: 1
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