FDA Adverse Event
Malfunction
Summary report: N
CONCERTO CRT-D DR
MDR report key: 3051091
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05894
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- February 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED A DATA RECORDING PROBLEM. CONCOMITANT MEDICAL PRODUCTS: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2004; 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY WERE UNABLE TO PRINT LEAD TREND DATA DUE TO "INVALID" MESSAGE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS DETERMINED THAT A BIT FLIP CAUSED THE INVALID DATA MESSAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153752 | CONCERTO CRT-D DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | C154DWK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | 4193 IMPLANTABLE PACING LEAD |