• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 07/19/2011
Event Type  Injury  
Event Description

Product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Event Description

Additional information was received regarding the patient. The patient had a fall on (b)(6) 2011. The patient fell on his generator and small lesion that dehisced slightly. The notes then went on to state that there was no open area. No infection was mentioned.

 
Event Description

Additional information was received that the patient was re-implanted after their explant due to an infection.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

It was initially reported that the patient had their generator and lead explanted due to an open wound and infection. The patient had fallen and the skin around the generator opened up. The lead and generator were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. The device history records were reviewed confirming sterilization of the lead and generator prior to distribution. Good faith attempts for more information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2283457
Report Number1644487-2011-02398
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number102R
Device LOT Number016250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/27/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/18/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2006
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: 10/07/2011 Patient Sequence Number: 1
-
-