FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 5280664
·
Received December 9, 2015
Report
- Report Number
- 2182208-2015-04196
- Event Type
- Malfunction
- Date Received
- December 9, 2015
- Report Date
- October 14, 2015
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING ANALYSIS IT WAS DETERMINED THAT THE UPPER CASE WAS BROKEN AND THE CABLE WAS DAMAGED AND BOTH WERE REPLACED. (B)(4).
Description of Event or Problem · 1
THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED WITH NO INFORMATION SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTU RER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813115 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |