FDA Adverse Event
Malfunction
Summary report: N
SCREW-IN
MDR report key: 1863128
·
Received October 9, 2010
Report
- Report Number
- 2649622-2010-10560
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- July 22, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THE VENTRICULAR PACING LEAD HAS STARTED TO SHOW AN INCREASE IN PACING THRESHOLDS. IT WAS ALSO REPORTED THAT THERE WERE VENTRICULAR HIGH RATES RECORDED THAT APPEAR TO BE NOISE. THE DEVICE IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention | 4968 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |