FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 2132033
·
Received June 16, 2011
Report
- Report Number
- 2183613-2011-00240
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
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 COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE PASSED ALL ELECTRICAL TESTS, AND NO VISUAL ANOMALIES WERE OBSERVED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS NOT SENSING APPROPRIATELY. THERE WERE PACER SPIKES IN THE QRS COMPLEX AND AFTER. THE PATIENT EXPERIENCED R ON T PHENOMENON, AND VENTRICULAR FIBRILLATION RESULTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5348 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |