FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 4152485
·
Received July 14, 2014
Report
- Report Number
- 3009448963-2014-00148
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 22, 2014
- Report Date
- June 24, 2014
- Manufacturer
- CAMERON HEALTH INC.
- Product Code
- NVY
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFO THAT ONE MONTH AFTER THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IMPLANTED. THE PT PRESENTED WITH REDNESS AT THE POCKET SITE AND THERE WAS PUS PRESENT ON THE WOUND. THE PT WAS HOSPITALIZED AND ADMINISTERED ANTIBIOTIC TREATMENT. THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410122 | S-ICD SYSTEM | IMPLANTABLE LEAD | NVY | CAMERON HEALTH INC. | 3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 1010 |