FDA Adverse Event
Malfunction
Summary report: N
S-ICD SYSTEM
MDR report key: 4180577
·
Received October 15, 2014
Report
- Report Number
- 3009448963-2014-00249
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 22, 2014
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- PMA / PMN Number
- P11042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PRIOR TO IMPLANT, WHEN INTERROGATING THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), A RED SCREEN APPEARED ON THE PROGRAMMER STATING "DO NOT IMPLANT THE DEVICE/INITIAL DEVICE CHECK UNSATISFACTORY". THE FIELD REPRESENTATIVE CONFIRMED THE DEVICE WAS NOT STORED IN COLD TEMPERATURE. FURTHER ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655775 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CAMERON HEALTH | 1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3010 |