FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 4163255
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12408
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 6, 2014
- Report Date
- August 6, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 PRODUCT: 4194 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WITHIN A FEW WEEKS OF IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE AND WAS FOUND TO HAVE DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, BUT WAS UNABLE TO GAIN APPROPRIATE POSITIONING. 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 |
|---|---|---|---|---|---|---|---|
| 643921 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | D314TRG ICD |