FDA Adverse Event
Injury
Summary report: N
SCREW-IN
MDR report key: 2791711
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14860
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEADS HAD HIGH THRESHOLD AND THE CURRENT PACEMAKER DOES NOT PROVIDE ENOUGH OF A SAFETY MARGIN. THE POCKET WILL BE OPENED AND THE LEADS WILL BE EVALUATED INDEPENDENTLY. THE LEADS CURRENTLY REMAIN 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 | 27 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR| 5866 IMPLANTABLE LEAD ADAPTOR |