FDA Adverse Event
Injury
Summary report: N
VIGILA 2CR 60/16 US
MDR report key: 2992863
·
Received March 1, 2013
Report
- Report Number
- 1028232-2013-00463
- Event Type
- Injury
- Date Received
- March 1, 2013
- Date of Event
- November 30, 2012
- Report Date
- February 18, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.
Description of Event or Problem · 1
(B)(6) REPORTED THAT THIS LEAD DISLODGED DUE TO TISSUE IN THE HOUSING OF THE LEAD.
Description of Event or Problem · 1
(B)(6) REPORTED THAT THIS LEAD DISLODGED DUE TO TISSUE IN THE HOUSING OF THE LEAD
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89320 | VIGILA 2CR 60/16 US | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 382924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |