FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2131002
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03429
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- April 22, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE DEVICE DELIVERED A SHOCK ON THE T-WAVE WITHOUT BEING TRIGGERED TO DO SO. THE PHYSICIAN DID NOT TRUST THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Life Threatening | 4194 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD |