FDA Adverse Event
Malfunction
Summary report: N
S-ICD SYSTEM
MDR report key: 4180560
·
Received October 15, 2014
Report
- Report Number
- 3009448963-2014-00260
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- August 27, 2014
- Report Date
- September 23, 2014
- Manufacturer
- CAMERON HEALTH
- Product Code
- NVY
- PMA / PMN Number
- P11042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 ON THE SAME DATE AS IMPLANT, TWO EPISODES WERE RECORDED WITHIN THIS DEVICES HISTORY. A TECHNICAL SERVICE DATA ANALYSIS CONFIRMED ONE ONE-SUSTAINED EPISODE AND A SUBSEQUENT EPISODE, WHICH DID RESULTED IN A SINGLE INAPPROPRIATE SHOCK. BOTH EPISODES WERE INITIATED DUE TO SYSTEM OVERSENSING WHICH COULD HAVE RESULTED FROM AIR ENTRAPMENT, DURING THE IMPLANT PROCEDURE. AT THIS TIME, NO INTERVENTION HAS BEEN PERFORMED AND THE PATIENT RELEASED; NO RESULTING ADVERSE EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655743 | S-ICD SYSTEM | IMPLANTABLE LEAD | NVY | CAMERON HEALTH | 3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1010 |