FDA Adverse Event
Injury
Summary report: N
SYMPHONY
MDR report key: 3201650
·
Received June 28, 2013
Report
- Report Number
- 9610579-2013-00050
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 20, 2013
- Manufacturer
- SORIN CRM
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
REPORTEDLY, ON (B)(6) 2013, IT WAS IMPOSSIBLE TO INTERROGATE THE PACEMAKER. IT WAS ATTEMPTED TO COMPLETELY RESET THE PACEMAKER; NEVERTHELESS THE SEVERAL ATTEMPTS PERFORMED HAD FAILED AND DEVICE INTERROGATION WAS STILL NOT SUCCESSFUL. THEREFORE, DEVICE REPLACEMENT HAS BEEN RECOMMENDED FOR THIS PT AND THE REPLACEMENT WAS SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296776 | SYMPHONY | NVZ | SORIN CRM | SYMPHONY SR 2250 | M061107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |