FDA Adverse Event
Injury
Summary report: N
CONFIENT
MDR report key: 3040857
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01586
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- December 31, 2012
- Report Date
- January 4, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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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
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THIS DEVICE WAS EXPLANTED AND USED AS A TEMPORARY PACEMAKER UNTIL THE NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143704 | CONFIENT | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | E030| 4136| 0158| 4473| S601| A135 |