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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

 
Event Description

It was reported that the patient was experiencing discomfort at the generator implant site and was concerned that the generator had moved into her armpit. There was more discomfort noted when a shoulder seat belt and backpack straps were present. The generator was noted to be palpable sitting medially to the anterior axillary line incision. The patient was referred for surgery where the generator was going to be repositioned and potentially replaced. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7074866
Report Number1644487-2017-04893
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2013
Device MODEL Number103
Device LOT Number201734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/03/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/06/2011
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: 12/01/2017 Patient Sequence Number: 1
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