FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 4162446
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12771
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 3, 2014
- Report Date
- August 3, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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: ADDR01 IPG, IMPLANTED (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE ASSESSED WITH THE PROGRAMMER AS IT HAD REACHED END OF LIFE (EOL). THE IPG WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH THRESHOLDS AND CAPTURING INTERMITTENTLY AT A HIGH OUTPUT. 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 |
|---|---|---|---|---|---|---|---|
| 639795 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4092-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Hospitalization| R | 4592-45 LEAD |