FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2951668
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00158
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 6, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 PRODUCTS : 4196 IMPLANTABLE PACING LEAD (B)(6) 2009; 4574 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO A RIGHT VENTRICULAR LEAD FRACTURE. NOISE WAS ALSO NOTED ON THE LEAD. THE LEAD WAS PARTIALLY EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE BATTERY PREMATURELY DEPLETED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57844 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE DEFIBRILLATOR |