FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3991747
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02105
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 13, 2014
- 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
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; ECG (ELECTROCARDIOGRAM) AND RF (RADIO FREQUENCY) HEAD CONNECTORS FOUND LOOSE ON A PRINTED CIRCUIT BOARD ASSEMBLY.
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).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE ECG (ELECTROCARDIOGRAM) PORT IS LOOSE AND NOISE IS COMING FROM IT. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468521 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 RADIO FREQUENCY HEAD |