FDA Adverse Event
Injury
Summary report: N
ACCUFIX
MDR report key: 1211134
·
Received October 24, 2008
Report
- Report Number
- 1723248-2008-00025
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 19, 2008
- Report Date
- October 24, 2008
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Removal / Correction Number
- Z-209/211/5
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO AN INFECTION WITHIN THE PATIENT'S BODY WHICH CAUSED THE LEAD AND PACEMAKER SYSTEM TO BECOME INFECTED. THE LEAD WAS EXPLANTED WITHOUT COMPLICATIONS. PER THE MEDICAL PROFESSIONAL, THE OCCURRENCE WAS NOT LEAD RELATED AND THE DEVICE DID NOT CONTRIBUTE TO ANY INJURY SUSTAINED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUFIX | PERM IMPL PACER ELECTRODE | DTB | TELECTRONICS PACING SYSTEMS | 330-801 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |