FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2203630
·
Received August 11, 2011
Report
- Report Number
- 2183613-2011-00393
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 26, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- Z-0430-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THE EXTERNAL PULSE GENERATOR (EPG) EXPERIENCED A SELF-TEST ERROR. THE ERROR WAS CLEARED WHEN THE BATTERY WAS REMOVED FOR FIFTEEN SECONDS AND REINSERTED. THE EPG POWERED ON WITH NO ERRORS AND REMAINS IN USE AT THE HOSPITAL. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |