FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3991255
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08231
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. CONCOMITANT: 429678 LEAD IMPLANTED: (B)(6) 2013; 5076-45 LEAD IMPLANTED: (B)(6) 2003. (B)(4). EVALUATION SUMMARY: THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POSSIBLE LEAD FRACTURE. 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 |
|---|---|---|---|---|---|---|---|
| 468483 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | Hospitalization| R | DTBA1D4 CRT-D |