FDA Adverse Event
Injury
Summary report: N
SELECT SECURE
MDR report key: 2790575
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14748
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 THE POSITION OF THE RIGHT ATRIAL (RA) LEAD WAS BELIEVED TO HAVE CHANGED AND THEREFORE UNDERSENSING THE PATIENT'S ATRIAL ARRHYTHMIAS. THE LEAD WAS CAPPED 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |