FDA Adverse Event
Malfunction
Summary report: N
PACEART SYSTEM
MDR report key: 2811200
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03704
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 17, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DPS
- PMA / PMN Number
- K024278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
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 THERE WAS A DISCREPANCY IN THE PATIENT'S BATTERY VOLTAGE MEASUREMENT BETWEEN THE SYSTEM AND THE APPLICATION FOR THE SAME TRANSMISSION. THE ISSUE WILL BE ESCALATED FOR FURTHER INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACEART SYSTEM | SOFTWARE | DPS | MEDTRONIC, INC. | GCIII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR |