FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 3990566
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08611
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 21, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 MEDICAL PRODUCTS: 5076-45, LEAD, IMPLANTED: (B)(6) 2014; 419688, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
AFTER A DIFFICULT IMPLANT, IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND THE PATIENT EXPERIENCED A PNEUMOTHORAX. IT WAS FURTHER REPORTED THAT THE LEAD WAS EXHIBITING NOISE AND WAS NOT CAPTURING THE VENTRICLE. THE LEAD WAS REPOSITIONED AND NORMAL FUNCTION RESUMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467146 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Hospitalization| R | DTBA1D4 ICD |