FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3071786
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05298
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- February 15, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS, CO., VILLALBA
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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. 7086 IMPLANTABLE PULSE GENERATOR 1994 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS "NOT ATTACHED PROPERLY". ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171155 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC PUERTO RICO OPERATIONS, CO., VILLALBA | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5524 IMPLANTABLE PACING LEAD |