LEAD MODEL 302
Report
- Report Number
- 1644487-2012-02451
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- July 9, 2010
- Report Date
- September 10, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
DATE OF EVENT, CORRECTED DATA: PREVIOUSLY SUBMITTED DATA INDICATED AN INCORRECT EVENT DATE. THE HIGH IMPEDANCE WAS FIRST SEEN ON (B)(4) 2010.
(B)(4). DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.
DATE RECEIVED BY MANUFACTURER (MO/DAY/YR), CORRECTED DATA: PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT 03 INDICATED A DATE RECEIVED BY MFR: DATE OF 03/13/2014; HOWEVER, THIS DATE SHOULD HAVE BEEN 03/10/2014. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS FIELD FROM SUPPLEMENTAL REPORT 03.
ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY
ANALYSIS OF PROGRAMMING HISTORY AND DECODER DATA DATE OF EVENT, CORRECTED DATA: REVIEW OF NEW INFORMATION SHOWED THAT THE EVENT DATE SHOULD BE (B)(6) 2010. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS FIELD.
DURING A REVIEW OF PROGRAMMING HISTORY ON A PHYSICIAN'S HANDHELD DEVICE ON (B)(6) 2012, IT WAS NOTED THAT A PATIENT'S DIAGNOSTIC RESULTS INDICATED HIGH IMPEDANCE. THE HHD SHOWED HIGH LEAD IMPEDANCE ON (B)(6) 2011. A REVIEW OF PROGRAMMING HISTORY SHOWED THAT THE HIGH IMPEDANCE WAS FIRST SEEN ON (B)(6) 2010. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S FAMILY DECIDED NOT TO REVISE AT THE TIME WHEN THE HIGH LEAD IMPEDANCE WAS INITIALLY SEEN ON (B)(6) 2012. (THE PATIENT'S SETTINGS AND SYSTEM DIAGNOSTICS FROM THAT DAY WERE PROVIDED.) IT WAS NOTED THAT THE DEVICE WAS NOT FUNCTIONING, BUT IT WAS UNCLEAR IF THE DEVICE WAS PROGRAMMED OFF AT THIS TIME. THE PATIENT WAS SEEN ON (B)(6) 2011, (B)(6) 2012 WITH NO NOTED INTERROGATIONS WITH DEVICE. IT WAS NOT CLEAR IF THE PATIENT WAS FEELING ANYTHING AS THE IT IS UNKNOWN IF THE PATIENT IS COMMUNICATIVE.
ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO X-RAYS HAD BEEN TAKEN. UPDATED PROGRAMMING HISTORY WAS REVIEWED. THE PATIENT'S DEVICE WAS DISABLED ON (B)(6) 2011. SURGERY IS LIKELY BUT HAS NOT OCCURRED.
ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT IS HAVING COUGHING AND GAGGING WITH MEALS AND HAS BEEN HOLDING HIS NECK LIKE IT IS PAINFUL. THE ISSUES ARE NOT CONSISTENT TIMES OR PATTERNS AND IT WAS UNCLEAR WHAT THE CAUSE OF THE ISSUE WAS. THE CURRENT X-RAYS WERE NOTED TO SHOW A LEAD FRACTURE, AND WHEN COMPARED TO PREVIOUS X-RAYS PERFORMED IN 2010, THERE WAS NO PREVIOUS LEAD ISSUE PRESENT. THE PHYSICIAN ALSO NOTED THAT UPON INTERROGATION THE PATIENT'S DEVICE SHOWED DISABLED AT 0MA. THE PATIENT WAS REFERRED FOR EXPLANT AND NO PLANS FOR REIMPLANT, BUT THE SURGEON DOESN'T KNOW IF THE COUGHING AND GAGGING WILL IMPROVE WITH EXPLANT. THE PATIENT'S LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013 DUE TO "LEAD FRACTURE WITH CONCERN OF FLUID LEAKAGE". THE PHYSICIAN LATER REPORTED THAT THE PATIENT DOES NOT HAVE A HISTORY OF COUGHING/GAGGING/NECK PAIN AND NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THESE EVENTS. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR PRODUCT ANALYSIS ON 10/01/2013. PRODUCT ANALYSIS ON THE LEAD FOUND THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS ABRADED OPENINGS WERE OBSERVED ON THE OUTER SILICONE TUBING. ABRADED OPENINGS WERE NOT OBSERVED ON THE INNER SILICONE TUBES. THE SLICE MARK AND ABRADED OPENINGS FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. THE CONDITION OF THE RETURNED LEAD PORTION 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 PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. DURING PRODUCT ANALYSIS ON THE GENERATOR AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.
REVIEW OF ADDITIONAL DATA SHOWED THAT A CHANGE IN IMPEDANCE FROM NORMAL VALUES TO HIGH IMPEDANCE VALUES (3482 OHMS TO 10201 OHMS) WAS DETECTED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 2004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |