FDA Adverse Event
Malfunction
Summary report: N
MARQUIS VR
MDR report key: 1875340
·
Received October 19, 2010
Report
- Report Number
- 2647346-2010-00661
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- December 1, 2009
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S29
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA WHICH REVEALED NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SENSING INTEGRITY COUNTER HAS BEEN INCREASING SINCE (B)(6) 2009, AND THAT A FEW NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WITH CYCLE LENGTH LESS THAN 220 MS HAD OCCURRED. THE DEVICE REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARQUIS VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7230CX | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | 0137 NON-MDT IMPLANTABLE TACHY LEAD |