FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 3051197
·
Received April 10, 2013
Report
- Report Number
- 2182208-2013-01058
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. CONCOMITANT PRODUCTS: 4968 X2 IMPLANTABLE PACING LEADS (B)(6) 2003. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE-OUT PROCEDURE, THE PHYSICIAN ACCIDENTALLY CUT THE ATRIAL LEAD RESULTING IN AN APPARENT CONDUCTOR FRACTURE. THE 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 |
|---|---|---|---|---|---|---|---|
| 151893 | CAPSURE EPI | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 4968-60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00028 YR | Hospitalization| R | 8042B IMPLANTABLE CARDIAC PACEMAKER |