FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1071992
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03808
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- 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 THAT THE PATIENT CAME TO THE ER (EMERGENCY ROOM) AFTER RECEIVING MULTIPLE SHOCKS. INTERROGATION OF THE DEVICE SHOWED NON-PHYSIOLOGIC SENSING. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED 60 SHOCKS FOR NOISE. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED WITH A NEW PACE/SENSE LEAD. THE HIGH VOLTAGE PORTION REMAINS IN USE. 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 | 59 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 7274 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |