SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2011-07589
- Event Type
- Injury
- Date Received
- May 18, 2011
- Date of Event
- May 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- Z-0475-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION RECEIVED INDICATED AN APPARENT CONDUCTOR FRACTURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, DEFIB CONDUCTOR DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY MELTED AND BREACHED CUT, EXPOSED DEFIB COIL WHITE SUBSTANCE, OUTER INSULATION COSMETIC DEPRESSION, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.
ASKU
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION RECEIVED INDICATED AN APPARENT CONDUCTOR FRACTURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.
ADDITIONAL INFORMATION RECEIVED INDICATED AN APPARENT CONDUCTOR FRACTURE. 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.
ADDITIONAL INFORMATION RECEIVED INDICATED AN APPARENT CONDUCTOR FRACTURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THE ATRIAL LEAD HAD BEEN OVERSENSING FOR SOME TIME AND THE DEVICE WAS PROGRAMMED TO VVI. THE VENTRICULAR LEAD BEGAN OVERSENSING AND "CREATED SYNCOPY EPISODE WITH TORSADES DE POINTE." IMPEDANCE WAS NOTED TO BE GREATER THAN 3000 OHMS. THE DEVICE WAS TURNED OFF AND AN EPG (EXTERNAL PULSE GENERATOR) WAS USED WITH A TEMPORARY LEAD. THE DEVICE WAS EXPLANTED AND AN IMPLANTABLE PULSE GENERATOR (IPG) AND NEW PACING LEAD WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PACEMAKER DEPENDENT.
ASKU
IT WAS REPORTED THE ATRIAL LEAD HAD BEEN OVERSENSING FOR SOME TIME AND WAS PROGRAMMED TO VVI. THE VENTRICULAR LEAD BEGAN OVERSENSING AND "CREATED SYNCOPY EPISODE WITH TORSADES DE POINTE." IMPEDANCE WAS NOTED TO BE GREATER THAN 3000 OHMS. THE DEVICE WAS TURNED OFF AND AN EPG (EXTERNAL PULSE GENERATOR) WAS USED WITH A TEMPORARY LEAD. THE DEVICE AND VENTRICULAR LEAD WERE EXPLANTED AND AN IMPLANTABLE PULSE GENERATOR (IPG) AND NEW PACING LEAD WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PACEMAKER DEPENDENT. FOLLOW UP REVEALED NO ISSUES WERE FOUND WITH THE ATRIAL LEAD WHICH REMAINS IN USE. THE PATIENT IS REPORTED TO BE DOING FINE.
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 | 16 YR | Hospitalization| L| R | 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD |