MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported during prophylactic generator replacement, the surgeon found the lead wiring out of the tubing.When the surgeon went to remove the generator from the pocket the lead broke in half.It was reported that device diagnostics prior to generator replacement were within normal limits.The explanted generator and lead were received for analysis.Analysis of the generator was completed on 02/08/2016.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead was completed on 02/02/2016.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned lead portions the quadfilar coils did not appeared to be broken and abraded openings were not observed on the outer or inner silicone tubes.Slice marks were observed in various areas on the outer silicone tubing.The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the 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, with no discontinuities identified.Based on the analysis results of the lead, it is likely that the damage to the lead occurred as a result of the surgery; however, attempts to obtain additional relevant information have been unsuccessful to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5432331
• MDR Text Key: 38784758
• Report Number: 1644487-2016-00287
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 302-20
• Device Lot Number: 929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR