FDA Adverse Event
Malfunction
Summary report: N
SCREW-IN
MDR report key: 2810849
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16557
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 12, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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 LEAD WAS IMPLANTED PAST THE "USED BEFORE DATE." THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 1 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | 5592 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD| D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |