FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 6048841
·
Received October 21, 2016
Report
- Report Number
- 2124215-2016-15689
- Event Type
- Malfunction
- Date Received
- October 21, 2016
- Date of Event
- September 5, 2016
- Report Date
- November 1, 2016
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS IS PENDING FOR THIS CASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION NOTED THAT THIS ISSUE HAS BEEN PREVIOUSLY REPORTED AND ADDRESSED IN REPORT 2124215-2016-16051 UNDER DEVICE P107/043055.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697744 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | P107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |