FDA Adverse Event
Other
Summary report: N
ICS 3000 PGH ICD
MDR report key: 2523330
·
Received April 2, 2012
Report
- Report Number
- 1028232-2012-00846
- Event Type
- Other
- Date Received
- April 2, 2012
- Report Date
- March 29, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR - THE ANALYSIS CONFIRMED THAT AN INCORRECT LABEL WAS AFFIXED TO THE PROGRAMMING HEAD OF THE DEVICE. THE ROOT CAUSE WAS FOUND TO BE AN OPERATOR ERROR. NO MANUFACTURE DATE WAS AVAILABLE.
Description of Event or Problem · 1
OUS MDR - AN INCORRECT LABEL WAS NOTED. THE EVENT DATE WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICS 3000 PGH ICD | PROGRAMMER/EXTERNAL PACEMAKER WAND | NVZ | BIOTRONIK SE & CO. KG | 363705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |