FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1861557
·
Received October 8, 2010
Report
- Report Number
- 2649622-2010-10030
- Event Type
- Injury
- Date Received
- October 8, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE ATTORNEY ALLEGED THAT THE PATIENT REQUIRED OPEN HEART SURGERY DUE TO TWO "RENTS" THAT THE PATIENT IS NOW CLAIMING WERE CAUSED BY THE IMPLANT SURGERY. ONE "RENT" WAS IN THE SUBCLAVICLE VEIN, THE OTHER IN THE RIGHT VENTRICULAR WALL. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR |