FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-D
MDR report key: 2529209
·
Received April 11, 2012
Report
- Report Number
- 6000144-2012-02058
- Event Type
- Malfunction
- Date Received
- April 11, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD FELT WORSE SINCE RECEIVING THIS REPLACEMENT DEVICE. THE PATIENT WAS SYMPTOMATIC WITH SHORTNESS OF BREATH AND PNEUMONIA. THERE WAS CONCERN THAT THE RATE RESPONSE ON THE DEVICE MAY NEED ADJUSTING. NO CHANGES WERE MADE TO THE DEVICE UNTIL THE PATIENT'S PULMONARY STATUS CLINICALLY IMPROVED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other | 6949 IMPLANTABLE TACHY LEAD| 4243 COMPETITOR IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |