FDA Adverse Event
Malfunction
Summary report: N
SELECT SECURE
MDR report key: 1991225
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02295
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- October 26, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD THRESHOLDS INCREASED PROGRESSIVELY AND SUDDENLY. IT WAS FURTHER REPORTED THAT THERE WAS FAILURE TO CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LEAD WAS NOTED TO BE PART OF THE SYSTEM LONGEVITY STUDY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD THRESHOLDS INCREASED PROGRESSIVELY AND SUDDENLY. THE LEAD REMAINS IN USE. 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 | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MEDTRONIC PUERTO RICO, INC. | 3830 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR| 3830 IMPLANTABLE PACING LEAD |