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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 Problems Generator; Loss of or Failure to Bond; Migration or Expulsion of Device ; Material Protrusion / Extrusion; Lead
Event Date 04/07/2015
Event Type  Injury  
Event Description

It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.

 
Event Description

It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

 
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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 Key5253695
Report Number1644487-2015-06589
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 11/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL Number103
Device LOT Number202947
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2014
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: 11/29/2015 Patient Sequence Number: 1
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