FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 1874633
·
Received October 19, 2010
Report
- Report Number
- 6000144-2010-05402
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 23, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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. EVALUATION SUMMARY: (B)(4) ANALYSIS REVEALED THAT THE DEVICE DID NOT MEET EXPECTED LONGEVITY, THE CAUSE IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS A POSSIBLE OCCULT DEFECT. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO CRT-D DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | C154DWK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | 6944 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD |