FDA Adverse Event
Injury
Summary report: N
ACCUFIX
MDR report key: 84003
·
Received April 11, 1997
Report
- Report Number
- 1723248-1997-00253
- Event Type
- Injury
- Date Received
- April 11, 1997
- Date of Event
- March 6, 1997
- Report Date
- April 8, 1997
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Removal / Correction Number
- Z-209/211/
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES THE J STIFFENER WIRE WAS FRACTURED APPROXIMETELY 9MM PROXIMAL OF THE WELD SITE. THE PROXIMAL SECTION OF J STIFFENER WIRE MEASURES APPROXIMETELY 79MM AND HAS MIGRATED DOWN LEAD BODY APPROXIMATELY 35MM PROXIMAL OF WELD SITE.
Description of Event or Problem · 1
DEVICE ANALYSIS IS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUFIX Implant | PERM IMPL PACER ELECTRODE | DTB | TELECTRONICS PACING SYSTEMS | 330-801 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |