FDA Adverse Event
Injury
Summary report: N
CONSULTA
MDR report key: 1875330
·
Received October 19, 2010
Report
- Report Number
- 6000144-2010-05480
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- July 1, 2010
- 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
- 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) THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOLLOWING DEFIBRILLATION THRESHOLD (DFT) TESTING. THE DEVICE WAS EXPLANTED DUE TO "HEADER ISSUES" AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |