SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2011-05618
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
IT WAS REPORTED THAT THE LEAD IMPEDANCE WAS OUT OF RANGE AND THERE MAY HAVE BEEN A FRACTURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIRECTED TO GO TO THE EMERGENCY DEPARTMENT (ED), THE LEAD EXHIBITED NOISE AND OVERSENSING, AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION EPISODES. THE LEAD WAS REMOVED AND ANOTHER WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE LEAD IMPEDANCE WAS OUT OF RANGE AND THERE MAY HAVE BEEN A FRACTURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIRECTED TO GO TO THE EMERGENCY DEPARTMENT (ED), THE LEAD EXHIBITED NOISE AND OVERSENSING, AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION EPISODES. THE LEAD WAS REMOVED AND ANOTHER WAS IMPLANTED. 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 | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD |