ENDOTAK RELIANCE
Report
- Report Number
- 2124215-2012-12756
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 18, 2012
- Report Date
- January 26, 2018
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO PALPITATIONS AND SYNCOPE. CONTINUED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WHICH YIELDED SUCCESSFUL CONVERSION OF THE PATIENT'S RHYTHM, THUS NO CHANGES WERE MADE TO THE SYSTEM AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN ALL VECTORS. IT WAS NOTED THAT THERE WAS NO OVERSENSING OBSERVED ON ANY OF THE STORED EPISODES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED PERFORMING INDUCTION TESTING, BUT DID STATE THAT THIS WOULD BE PHYSICIAN'S DISCRETION. THE FIELD REPRESENTATIVE WILL DISCUSS OPTIONS WITH THE PHYSICIAN. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION RELATING TO THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT A CHEST X-RAY WAS TAKEN AND DID NOT REVEAL ANY ISSUES. SUBSEQUENTLY A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE WAS PERFORMED AND YIELDED NORMAL MEASUREMENTS. HOWEVER ALL IN-OFFICE AND DAILY MEASUREMENTS ARE STILL MEASURING OUT OF RANGE. THE DEVICE'S MEMORY WAS PRESERVED TO A DISK AND SENT IN FOR ANALYSIS. UPON REVIEW, ENGINEERING NOTED THAT ALL OF THE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN OUT OF RANGE FOR OVER A YEAR. TECHNICAL SERVICES ADVISED THAT ADDITIONAL TESTING BE PERFORMED TO HELP DETERMINE THE CAUSE OF THE OUT OF RANGE IMPEDANCE MEASUREMENTS. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN RESOLUTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S REMOTE MONITORING SYSTEM DISPLAYED A RED BLINKING LIGHT INDICATING THE PRESENCE OF A POTENTIAL PRODUCT PERFORMANCE ISSUE. THE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WAS NOT BROUGHT INTO THE OFFICE FOR INTERROGATION AFTER THE RED BLINKING LIGHT OCCURRED. IT WAS NOTED THAT THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD HAVE A HISTORY OF HIGH SHOCKING IMPEDANCE MEASUREMENTS. THERE ARE NO PLANS TO PERFORM ANY ADDITIONAL INTERVENTION AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE CONTINUED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. DURING THE PROCEDURE NO LEAD INTEGRITY ISSUES WERE IDENTIFIED. THE RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. THE ICD REMAINED IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT AT THIS TIME THERE HAS BEEN NO REPROGRAMMING OR SURGICAL INTERVENTION. THE FIELD REPRESENTATIVE INTENDS TO DISCUSS THE SITUATION AGAIN WITH THE PHYSICIAN TO DETERMINE IF THE PHYSICIAN WILL INTERVENE AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization | E110| 4136 |