FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 3860285
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-10586
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 7, 2014
- Report Date
- June 3, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AND THE DEVICE DID NOT RECORD AN EVENT. THE DEVICE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342623 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00027 YR | Hospitalization| R |