FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3152309
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06866
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 18, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A BREACH IN THE RIGHT ATRIAL LEAD INSULATION IDENTIFIED BY X-RAY AND CONFIRMED DURING THE LEAD REPLACEMENT PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS LOW IMPEDANCE AND NOISE OBSERVED IN THE ATRIAL LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 252638 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 559453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Hospitalization| R | VEDR01 IMPLANTABLE PULSE GENERATOR (IPG) |