FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL TR
MDR report key: 2170119
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09662
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 4, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, AN INFECTION WAS NOTED AT THE DEVICE POCKET SITE. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME. IT IS UNKNOWN WHETHER THE LEADS ARE BOSTON SCIENTIFIC LEADS. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL TR | IMPLANTABLE CHF GENERATOR | NKE | GUIDANT CRM CLONMEL IRELAND | H140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |