FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2811510
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-17114
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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 BY THE PATIENT THAT THEY STRAINED THEIR UPPER BODY WORKING ON A PROJECT AND IT CAUSED THE RIGHT ATRIAL (RA) LEAD TO FRACTURE. THE PATIENT INDICATED THE RA LEAD WAS PROGRAMMED OFF AT THAT TIME ABOUT TWO YEARS AGO SINCE THE PATIENT DID NOT USE THE LEAD. IT WAS RECENTLY DETERMINED THE PATIENT DID NEED A RA LEAD, SO THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | (B)(4) COMPETITOR IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD |