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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problems High impedance; Migration or Expulsion of Device
Event Date 01/01/2015
Event Type  Injury  
Event Description

It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.

 
Manufacturer Narrative

 
Event Description

Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of corrosion on the lead was previously reported in manufacturer report # 1644487-2015-04810.

 
Event Description

Additional information was received from the explant facility that the explanted products will not be returned.

 
Event Description

It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on 08/14/2015. Analysis is underway but has not been completed to date. New information was also received stating the voice hoarseness the patient experienced was sometimes caused by stimulation.

 
Manufacturer Narrative

The supplemental 04 mfr report was stated to be 09/13/2014. This was mistakenly reported and the actual date was 09/13/2015.

 
Manufacturer Narrative

Describe event or problem; corrected data: the information regarding the return of the lead was originally and inadvertently reported in mfr. Report # 1644487-2015-04809, supplemental report #03.

 
Event Description

It was reported the hospital was able to find the explanted generator. The explanted generator was received by the manufacturer on 08/14/2015. Analysis is underway, but has not been completed to date. The explanted lead is captured in mfr. Report # 1644487-2015-04810.

 
Event Description

A user facility medwatch report (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient.

 
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Brand NamePULSE GEN MODEL 102
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 Key4808411
Report Number1644487-2015-04809
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility,Company Representative,COMPANY REPRESENT
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/15/2011
Device MODEL Number102
Device LOT Number201228
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age5 yr
Event Location Home
Date Manufacturer Received10/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2009
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: 06/01/2015 Patient Sequence Number: 1
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