FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 1925555
·
Received December 14, 2010
Report
- Report Number
- 2182208-2010-01001
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS USING AN EXTERNAL PULSE GENERATOR IN DDD PACING MODE, SET TO 80 BEATS PER MINUTE (BPM), WITH AN ATRIAL WIRE, AND WITH NO VENTRICULAR WIRE. IT WAS FURTHER REPORTED THAT WHEN THE GENERATOR VENTRICULAR OUTPUT (NOT RATE) WAS TURNED DOWN, THE PATIENT'S HEART RATE DECREASED TO APPROXIMATELY 60 BPM. THE STATUS OF THE DEVICE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN 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, INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |