SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2010-12874
- Event Type
- Injury
- Date Received
- December 13, 2010
- 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
- TX, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) A PORTION OF THE LEAD WAS RECEIVED IN SEGMENTS AND NO ANOMALIES WERE FOUND. SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID ON THEM. THERE WAS A DEFIB CONDUCTOR FRACTURE (OVERSTRESS); BLOOD/BODY FLUID IN OUTER TUBING OVERLAY; OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING; OUTER TUBING OVERLAY BREACHED CUT; EXPOSED DEFIB COIL HAD WHITE SUBSTANCE AND COSMETIC DEPRESSION. APPARENT EXPLANT DAMAGE.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPERIENCING INCREASING THRESHOLDS AND DECREASING SENSING.THE LEAD WAS EXPLANTED AND REPLACED. 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 | 59 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 7271 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7271 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |