FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 7616121
·
Received June 19, 2018
Report
- Report Number
- 2649622-2018-10199
- Event Type
- Injury
- Date Received
- June 19, 2018
- Date of Event
- May 24, 2018
- Report Date
- June 26, 2018
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169708198
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE REMOVED SYSTEM WAS FOR A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), NOT A CRT-D.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND HAD BECOME SEPTIC. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456669 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 | 00643169708198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 4076 LEAD, 3830 LEAD, W1TR01 CRT-P |