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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR Back to Search Results
Model Number 105
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 05/01/2015
Event Type  Injury  
Manufacturer Narrative
 
Event Description
On (b)(6) 2015 it was reported that the patient's generator migrated into the lower ribcage area and the patient was complaining of tightness in the neck.Diagnostics were good.Clinic notes were received on (b)(6) 2015 which indicated the patient is having swelling on the left side of her neck, along the vns leads.It was also noted that the vns generator has a palpable edge that is causing the patient pain.The physician noted that the patient has grown two cup sizes since the vns was implanted.The patient feels that a revision is justified based on her current level of discomfort.The patient underwent a generator pocket revision surgery on (b)(6) 2015.Good faith attempts for further information from the physician were unsuccessful.
 
Event Description
The physician confirmed that a non-absorbable suture was used to secure the generator during implant.
 
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Brand Name
PULSE GEN MODEL 105
Type of Device
GENERATOR
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 Key5072957
MDR Text Key25620096
Report Number1644487-2015-05753
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/18/2016
Device Model Number105
Device Lot Number203064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/18/2015
Initial Date FDA Received09/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age17 YR
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