FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1803287
·
Received August 17, 2010
Report
- Report Number
- 2649622-2010-08828
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- June 10, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THE PATIENT HAD A SHOCK DUE TO TWAVE OVERSENSING. THE PATIENT NORMALLY RUNS SINUS BRADYCARDIA AT 50-60, BUT RECENTLY HAS AN INTRINSIC RATE OF 90 BPM. THERE WERE 230 NST EPISODES OBSERVED. IT WAS NOTED THAT WITH CHRONIC LEADS IN PLACE, THE POTENTIAL EXISTS FOR LEAD TO LEAD INTERACTION. THE DEVICE AND THE LEAD WERE 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 | SPRINT QUATTRO SECURE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |