FDA Adverse Event
Malfunction
Summary report: N
OVATIO
MDR report key: 1628945
·
Received March 9, 2010
Report
- Report Number
- 9610579-2010-00490
- Event Type
- Malfunction
- Date Received
- March 9, 2010
- Date of Event
- February 17, 2010
- Report Date
- February 18, 2010
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P060027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE US. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE ICD INVOLVED IN THIS MDR REPORT WAS IMPLANTED ON (B)(6) 2006. UPON A F/U PERFORMED ON (B)(6) 2010, NOISE OVERSENSING WAS OBSERVED, WHICH LED TO INAPPROPRIATE THERAPY (SHOCK). THE PT REPORTED THAT HE WAS USING A SLOT MACHINE WHEN HE RECEIVED THE SHOCK. THE RELATED EPISODE DATED (B)(6) 2010 17:35 SHOWS CLEARLY EMI SENSING. THIS EPISODE ALSO SHOWS VENTRICULAR PAUSES (UP TO 10 SEC) ALTHOUGH THE ICD WAS PROGRAMMED IN DDD/60 MIN-1. NO NOISE MARKERS WERE VISIBLE. QUESTIONS RAISED ABOUT THE NUMBER OF AV COMMITTED PACING, AND THE COUNTER FOR "VV DELAY=0 IN DETECTION ZONE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVATIO | MRM | SORIN CRM | OVATIO CRT 6750 | M060421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |