FDA Adverse Event
Injury
Summary report: N
SCREW-IN
MDR report key: 1923176
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-13288
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- October 6, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 HELIX WAS DISTORTED/BENT DURING INSERTION USING A THOROSCOPIC PROCEDURE ON THE FIRST EPICARDIAL LEAD. THE SECOND EPICARDIAL LEAD WAS INADVERTANTLY DROPPED ON THE FLOOR DUE TO PHYSICIAN DEPLOYMENT OF THE IMPLANT TOOL PLUNGER. A DIFFERENT EPICARDIAL LEAD WAS SUCCESSFULLY IMPLANTED. DURING THE PROCEDURE, THE ATRIAL LEAD WAS DISCOVERED TO BE DISLODGED VIA X-RAY AND SYSTEM TESTING. THE ATRIAL LEAD WAS REVISED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS 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 | 83 YR | Hospitalization| R |