FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3992978
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09538
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 10, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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: 457445 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT LIA (LEAD INTEGRITY ALERT) TRIGGERED, WITH "OBVIOUS NOISE", HIGH SIC (SENSING INTEGRITY COUNTER) AND NS (NON-SUSTAINED) EVENTS, ERRATIC PACING IMPEDANCES, AND LEAD FRACTURE NOTED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED, A NEW PACE/SENSE LEAD WAS IMPLANTED, AND THE DEFIBRILLATION PORTION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467073 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R | D314DRG ICD |