FDA Adverse Event
Injury
Summary report: N
SELECT SECURE
MDR report key: 2203803
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11738
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- April 10, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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
INFECTION WAS REPORTED. PATIENT IS REPORTED TO HAVE BLOOD CULTURES POSITIVE FOR (B)(4). THE DEVICE AND THE LEADS WERE REMOVED AND AN INTRAVENOUS LINE WAS PLACED FOR SIX WEEKS OF ANTIBIOTICS. THE DEVICE SYSTEM WAS SUBSEQUENTLY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELECT SECURE | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 3830 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | (B)(4) TISSUE VALVE |