FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3051053
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04742
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- February 12, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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: 5568 IMPLANTABLE PACING LEAD (B)(6) 1998. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED OUT AND FELL. INTERROGATION REVEALED A VENTRICULAR LEAD WARNING FOR IMPEDANCE AND INAPPROPRIATE INHIBITION. THE LEAD WAS FELT TO BE FRACTURED BY THE PHYSICIAN. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153598 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR | Hospitalization| R | VEDR01 IMPLANTABLE PULSE GENERATOR |