FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 2203334
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-12323
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- May 28, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S039
- Removal / Correction Number
- Z-0474-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST IMPLANT THE LEAD'S SENSING VALUE DECREASED. THE LEAD DISLODGED AND THE DEVICE MIGRATED RESULTING IN BOTH BEING REPOSITIONED TWICE DURING THE FIRST FEW DAYS AFTER IMPLANT. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE DISLODGEMENT WAS A DRUG INTERACTION THAT INDUCED BODY MOVEMENT AND AN ALTERED MENTAL STATE. THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE S | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6935 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |