FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 255250
·
Received July 26, 1999
Report
- Report Number
- 2649622-1999-00318
- Event Type
- Injury
- Date Received
- July 26, 1999
- Date of Event
- May 12, 1999
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
LOSS OF V SENSING, PROGRAMMED TO UNIPOLAR, STILL IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP Implant | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4024 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other | 4524 IMPLANTABLE PACING LEAD| 7074 IMPLANTABLE PULSE GENERATOR |