FDA Adverse Event
Injury
Summary report: N
SELECTSECURE
MDR report key: 7616093
·
Received June 19, 2018
Report
- Report Number
- 2649622-2018-10200
- Event Type
- Injury
- Date Received
- June 19, 2018
- Date of Event
- May 24, 2018
- Report Date
- June 26, 2018
- Manufacturer
- MPRI
- Product Code
- NVN
- UDI-DI
- 00643169857681
- PMA / PMN Number
- P030036
- 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 |
|---|---|---|---|---|---|---|---|
| 456160 | SELECTSECURE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 383069 | 00643169857681 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 4076 LEAD (X2), W1TR01 CRT-P |