FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 3863339
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06633
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- February 19, 2014
- Report Date
- May 24, 2024
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00613994249890
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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 MEDICAL PRODUCTS: DDBB1D1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPEDANCE READING ON THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR (RV) LEAD WAS OUT OF RANGE HIGH. THE DEFIBRILLATION CIRCUIT FUNCTION WAS TESTED VIA NONINVASIVE PROGRAMMED STIMULATION (NIPS) AND THE DECISION WAS MADE TO TURN OFF THE SVC COIL. THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 338992 | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 | 00613994249890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention | 5076-52 IMPLANTABLE PACING LEAD| 5076-52 IMPLANTABLE PACING LEAD |