FDA Adverse Event
Injury
Summary report: N
SYMPHONY
MDR report key: 3873869
·
Received June 16, 2014
Report
- Report Number
- 1000165971-2014-00357
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- June 9, 2014
- Report Date
- June 12, 2014
- Manufacturer
- SORIN CRM
- Product Code
- NVZ
- PMA / PMN Number
- PP950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.
Description of Event or Problem · 1
REPORTEDLY, THE PHYSICIAN COMPLAINED THAT DURING DEVICE REPLACEMENT, ONE OF THE SETSCREWS WAS VERY DIFFICULT TO RELEASE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
REPORTEDLY, THE PHYSICIAN COMPLAINED THAT DURING DEVICE REPLACEMENT, ONE OF THE SETSCREWS WAS VERY DIFFICULT TO RELEASE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
REPORTEDLY, THE PHYSICIAN COMPLAINED THAT DURING DEVICE REPLACEMENT, ONE OF THE SETSCREWS WAS VERY DIFFICULT TO RELEASE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352495 | SYMPHONY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN CRM | SYMPHONY DR 2550 | S080130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |