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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 Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2017
Event Type  Injury  
Event Description

It was reported that the patient experiences pain at the generator site when lying on left side, migration of the device and intermittent arrhythmia with stimulation. Patient mentioned that she hasn't ever been able to sleep on her left side because it causes some discomfort where the generator is located. It was described that it felt like her heart was "beating against the generator" even though she knew they weren't physically touching. She also mentioned that for about two weeks, she has felt like her heart was racing and pounding, which was intermittent and not with every stimulation. Then one day patient felt that her heart racing was more consistent with what felt like every stimulation on-time. Patient was told to go to er and the er physician instructed her to tape the magnet over her device to stop the stimulation, which appeared to resolve the issue. While in the er, it was confirmed that her heart rate (hr) was rising to about 105-110 beats per minute (bpm), but when the magnet was taped over, her hr dropped and remained about 80bpm. The patient then saw her neurologist and had the device turned off. The patient confirmed that diagnostics were performed as the physician told her it was functioning properly. It was then mentioned that she can move the generator around with her hand from her armpit to chest, which has been like this for some time. Per a nurse at the neurologist office, the first time patient reported about the heart beating against the device was on (b)(6) 2017. No known interventions were taken for the chest pain or migration and no known trauma or manipulation were involved. The patient underwent generator replacement and the explanted generator was discarded.

 
Manufacturer Narrative

If explanted, give date (mo/day/yr), corrected data: (b)(6) 2017. Initial mdr inadvertently listed the explant date as (b)(6) 2017 instead of (b)(6) 2017.

 
Event Description

Additional information was received from implanting surgeon confirming that non-absorbable suture was used during patient's implant surgery to secure the generator to fascia.

 
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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 Key6499756
Report Number1644487-2017-03632
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number103
Device LOT Number3495
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2012
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: 04/18/2017 Patient Sequence Number: 1
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