FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 1770927
·
Received July 27, 2010
Report
- Report Number
- 2649622-2010-06884
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- May 4, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S039
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
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 PACING THRESHOLD ON THE VENTRICULAR LEAD HAD INCREASED FROM 1V @ 0.1MS TO 2.25V @ 0.3MS FOUR WEEKS AFTER IMPLANT. THE COMPANY TECHNICAL REPRESENTATIVE DISCUSSED THE POSSIBILITY OF DISLODGMENT OR MEDICATION CHANGES AS POSSIBLE CAUSES OF THE OBSERVED THRESHOLD INCREASE. THE DEVICE 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 | SPRINT QUATTRO SECURE S | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6935 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |