FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2810393
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03676
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 4, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. THE RF (RADIO FREQUENCY) HEAD CABLE INSULATION HAS A LARGE CUT IN IT, PAST THE SHIELDING AND INTO THE WIRES. FURTHER ANALYSIS REVEALED A BROKEN MAGNET AND UPPER CASE.
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER RF (RADIO FREQUENCY) HEAD INSULATION WAS BROKEN ON THE CABLE. IT WAS ALSO REPORTED THAT THE INSULATION BREACH WAS DISCOVERED VISUALLY DURING AN INTERROGATION OF A PATIENT'S DEVICE. THE RF HEAD WAS RETURNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER RF HEAD | KRG | MEDTRONIC, INC. | 2067L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |