CONCERTO II CRT-D
Report
- Report Number
- 6000144-2011-03550
- Event Type
- Malfunction
- Date Received
- June 11, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S125
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: A CORRECTION TO MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8 FOR (B)(4).
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT ALERT TONE WAS GOING OFF ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS A WARNING THAT THE CARELINK MONITOR DID NOT PICK UP THE ICD SIGNAL AND FAILED TO SEND A CARELINK TRANSMISSION. THE DEVICE REMAINS IN USE, AND THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT ALERT TONE WAS GOING OFF ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS A WARNING THAT THE CARELINK MONITOR DID NOT PICK UP THE ICD SIGNAL AND FAILED TO SEND A CARELINK TRANSMISSION. THE DEVICE REMAINS IN USE, AND THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO II CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D274TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other | 2187 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 2187 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |