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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 Migration or Expulsion of Device
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the vns patient's device had migrated under the armpit. The patient was scheduled for repositioning surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the patient underwent repositioning surgery on (b)(6) 2015. It was noted that surgery was not to preclude a serious injury to the patient but for patient comfort. The physician indicated that trauma most like had occurred which contributed to the reported event and confirmed that a non-absorbable suture was used for the initial implant procedure; however, the generator had rotated 180 degrees around the suture.

 
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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 Key5179328
Report Number1644487-2015-06236
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2016
Device MODEL Number102R
Device LOT Number203052
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/23/2014
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: 10/27/2015 Patient Sequence Number: 1
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