CONCERTO CRT-D DR
Report
- Report Number
- 6000144-2010-05250
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- August 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONTINUATION OF EVENT DESCRIPTION: IT WAS FURTHER REPORTED THAT A SAVE-TO-DISK (STD) FILE WAS RETURNED TO ALLOW EVALUATION OF BATTERY STATUS AND WARRANTY REQUEST. THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (DATE OF DEATH TO NOT APPLICABLE, PATIENT OUTCOME CHECKED HOSPITALIZATION), EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THAT BATTERY DEPLETION WAS INDICATED (ELECTIVE REPLACEMENT INDICATION - ERI). ERI WAS REACHED ON (B)(6) 2010 AT 2.61 V. ICD LONGEVITY TOOL INDICATES THAT THE DEVICE MET OR EXCEEDED MEAN LONGEVITY BASED ON SETTINGS AVAILABLE IN THE SAVE TO DISK FILE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE SAVE-TO-DISK (SRD) IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD PREMATURELY REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) AND THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH CAPTURE THRESHOLDS REQUIRING THE OUTPUT TO BE PROGRAMMED AT 5.0 VOLTS/1.5 MSEC. IT WAS ALSO REPORTED THAT THE PATIENT HAS A MALIGNANT, METASTATIC MELANOMA OVERLYING THE RIGHT PECTORAL DEVICE IMPLANT SITE. THE PHYSICIAN ELECTED NOT TO REMOVE THE SYSTEM DUE TO THE MALIGNANT MELANOMA AND A POOR PROGNOSIS FOR THE PATIENT. THE SYSTEM WAS TURNED OFF FOR ALL THERAPIES EXCEPT BI-VENTRICULAR PACING WHICH WILL CONTINUE UNTIL THE DEVICE REACHES END OF SERVICE (EOS). A NEW, SINGLE CHAMBER, DEFIBRILLATOR AND RV PACE/SENSE/DEFIBRILLATOR LEAD WERE IMPLANTED ON THE LEFT SIDE TO PROVIDE TACHYCARDIA/DEFIBRILLATION THERAPIES AND BACK-UP VVI PACING FOR WHEN THE OLD SYSTEM REACHES EOS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD PREMATURELY REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) AND THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH CAPTURE THRESHOLDS REQUIRING THE OUTPUT TO BE PROGRAMMED AT 5.0 VOLTS/1.5 MSEC. IT WAS ALSO REPORTED THAT THE PATIENT HAS A MALIGNANT, METASTATIC MELANOMA OVERLYING THE RIGHT PECTORAL DEVICE IMPLANT SITE. THE PHYSICIAN ELECTED NOT TO REMOVE THE SYSTEM DUE TO THE MALIGNANT MELANOMA AND A POOR PROGNOSIS FOR THE PATIENT. THE SYSTEM WAS TURNED OFF FOR ALL THERAPIES EXCEPT BI-VENTRICULAR PACING WHICH WILL CONTINUE UNTIL THE DEVICE REACHES END OF SERVICE (EOS). A NEW, SINGLE CHAMBER, DEFIBRILLATOR AND RV PACE/SENSE/DEFIBRILLATOR LEAD WERE IMPLANTED ON THE LEFT SIDE TO PROVIDE TACHYCARDIA/DEFIBRILLATION THERAPIES AND BACK-UP VVI PACING FOR WHEN THE OLD SYSTEM REACHES EOS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO CRT-D DR | ASKU | NIK | MEDTRONIC MED REL, INC. | C154DWK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |