FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2910683
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-15662
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- July 1, 2012
- Report Date
- April 2, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P010012/S165
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO OTHER OBSERVATIONS HAVE BEEN REPORTED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT WAS EVALUATED IN THE CLINIC AND DURING TESTING WITH ISOMETRICS THE DEVICE RETURNED A SHOCK IMPEDANCE MEASUREMENT OF 80 OHMS IN THE TRIAD CONFIGURATION. THE PATIENT WAS TO BE FURTHER EVALUATED IN THE NEAR FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17847 | COGNIS | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | N119 | 022797 | |
| 17848 | COGNIS | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | N119 | 022797 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Life Threatening| H| R | 0185| 4136| 4543| N119| 4543| 0185| N119| 4136 |