FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3152266
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06883
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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: 4092 IMPLANTABLE PACING LEAD: (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WHO WAS IN THE HOSPITAL POST THORACIC SURGERY, SHOWED RIGHT ATRIAL (RA) LEAD OVERSENSING ALONG WITH NO CAPTURE AT HIGH OUTPUT. THERE APPEARS TO BE NOISE NOTED ON THE ELECTROGRAM FROM CAUTERY USED DURING THE THORACIC PROCEDURE. THE RA LEAD WAS REPROGRAMMED TO INACTIVE AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252303 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4592-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention | ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) |