FDA Adverse Event
Injury
Summary report: N
ACCUFIX
MDR report key: 104820
·
Received July 9, 1997
Report
- Report Number
- 1723248-1997-00529
- Event Type
- Injury
- Date Received
- July 9, 1997
- Date of Event
- March 1, 1995
- Report Date
- July 7, 1997
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Removal / Correction Number
- Z-2095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATED NO "J" WIRE DISCREPANCIES. X-RAY OF LEAD CONFIRMS NO "J" STIFFENER WIRE DISCREPANCIES.
Description of Event or Problem · 1
EXPLANT METHOD: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET NO COMPLICATIONS 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 | 74 YR | Required Intervention |