FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, EXTERNAL
MDR report key: 2952270
·
Received February 9, 2013
Report
- Report Number
- 2183613-2013-00103
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A MAINTENANCE CHECK, THE EXTERNAL PULSE GENERATOR (EPG) WAS POWERED ON, AND THE SCREEN WENT "BLANK." OF NOTE, THE BATTERY WAS LOW, AND TECHNICAL SERVICES SUGGESTED PUTTING A NEW BATTERY IN AND THE EPG WORKED "WELL." THE MANUAL FOR THE EPG WAS EMAILED TO THE CALLER. THE EPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56164 | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |