FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3993895
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09056
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 MEDICAL PRODUCTS: 6947-65 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SUPRA VENTRICULAR TACHYCARDIA (SVT) ABLATION, THE ABLATION CATHETER GOT TANGLED AROUND THE RIGHT ATRIAL (RA) LEAD AND CAUSED IT TO DISLODGE FROM THE RA LATERAL FREE WALL. THE RA THRESHOLD HAD INCREASED AND THE LEAD HAD HIGH IMPEDANCE. THE RA LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470361 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00041 YR | Hospitalization| R | D314TRG ICD, 4196-88 LEAD |