SPRINT QUATTRO
Report
- Report Number
- 2649622-2013-02578
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- February 23, 2013
- Report Date
- February 28, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). CONCOMITANT PRODUCT: D284DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2011; 5076-58 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2011.
PRODUCT EVENT SUMMARY: (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND NO ANOMALIES WERE FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PERFORMANCE DATA NOTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(6) 2013. VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 210 MILLISECONDS (MS) OCCURRED BETWEEN (B)(6) 2013. VENTRICULAR FIBRILLATION LESS THAN 130MS AVERAGE VENTRICULAR CYCLE ON (B)(6) 2013. THERE WERE VENTRICULAR SHORT INTERVAL COUNTS EQUAL TO 4805 BETWEEN (B)(6) 2013. THE DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR VENTRICULAR PACING BIPOLAR IMPEDANCE FROM 532 OHMS TO 4047 OHMS PEAK BETWEEN (B)(6) 2013.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE PATIENT RECEIVED EIGHT SHOCKS AND THAT A LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, NOISE AND A FRACTURE WAS SUSPECTED OF THE RIGHT VENTRICULAR LEAD. DURING EXTRACTION OF THE PACING AND TACHY LEADS THE PATIENT HAD A DECREASE IN VITAL SIGNS AND WAS TAKEN URGENTLY TO SURGERY. THE LEADS WERE REMOVED AND REPLACED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE. THE CURRENT STATUS OF THE PATIENT HAS BEEN REQUESTED AND NOT RECEIVED.
IT WAS REPORTED THE PATIENT RECEIVED EIGHT SHOCKS AND THAT A LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, NOISE AND A FRACTURE WAS SUSPECTED OF THE RIGHT VENTRICULAR LEAD. DURING EXTRACTION OF THE PACING AND TACHY LEADS THE PATIENT HAD A DECREASE IN VITAL SIGNS AND WAS TAKEN URGENTLY TO SURGERY. THE LEADS WERE REMOVED AND REPLACED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE. THE CURRENT STATUS OF THE PATIENT HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126973 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00012 YR | Hospitalization| L| R |