FDA Adverse Event
Injury
Summary report: N
CARELINK
MDR report key: 3994066
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02278
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 16, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER POWERED DOWN DURING A DEVICE INTERROGATION. TECHNICAL SERVICES DISCUSSED THE ERROR WITH THE CALLER. THE CALLER WAS ABLE TO POWER THE PROGRAMMER BACK ON AND THE INTERROGATION WAS SUCCESSFULLY COMPLETED. THE PROGRAMMER 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 |
|---|---|---|---|---|---|---|---|
| 471572 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |