FDA Adverse Event
Injury
Summary report: N
SELECT SECURE
MDR report key: 2090405
·
Received May 16, 2011
Report
- Report Number
- 2649622-2011-07560
- Event Type
- Injury
- Date Received
- May 16, 2011
- Date of Event
- March 31, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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
IT WAS REPORTED THAT THERE WAS A "LEAD MALFUNCTION." THE LEAD WAS EXPLANTED AND REPLACED. NO 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 | 7 YR | Hospitalization| R | D274DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |