• 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. BIPOL LEAD MODEL 300

  • 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. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem High impedance
Event Date 08/24/2015
Event Type  Malfunction  
Event Description

During a generator replacement surgery on (b)(6) 2015, high impedance was observed with the newly implanted generator. When connected to the old lead with > 10. 000 ohms. The lead pin was removed and re-inserted and the impedance was ok with 2614 ohms. When the generator was placed in the generator pocked, high impedance was again seen with impedance > 10. 000 ohms. The surgeon then repositioned the generator in pocket and checked again with results showing impedance of 6013 ohms. The surgeon then made a more superficial pocket and placed generator inside. Diagnostics showed normal impedance of 2339 ohms, 3254 ohms and 2483 ohms for subsequent diagnostics. The lead was not replaced at this time. Patient's vns was later programmed on in the recovery room. The explanted generator was received on (b)(6) 2015 but analysis has not been completed to date. During the post-op follow up appointment at the surgeon's office, patient's device was interrogated and high impedance was observed again. Multiple diagnostics done in different positions all resulting in impedance of greater than 10,000 ohms. Vns output current and magnet current were programmed to 0 ma. Patient underwent full revision surgery of the generator and lead on (b)(6) 2015. Product return of the suspected lead is expected but has not been received to date.

 
Event Description

Analysis was completed on the generator explanted on (b)(6) 2015. The pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The suspect lead and generator explanted on (b)(6) 2015 were received on (b)(4) 2015 but analysis has not been completed to date.

 
Event Description

Analysis was completed on the generator and lead. The battery voltage for the generator was 2. 729 volts (at ifi) the battery is partially depleted. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. A coil break was identified and it was determined to be a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Pitting on the coil and fluid leak on the outer silicone tubing was also observed during analysis. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 Key5085207
Report Number1644487-2015-05814
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Followup,Followup
Report Date 08/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2002
Device MODEL Number300-20
Device LOT Number1402
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/22/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-