FDA Adverse Event
Malfunction
Summary report: N
KAINOX SL 75/16
MDR report key: 3060851
·
Received April 16, 2013
Report
- Report Number
- 1028232-2013-01043
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- March 13, 2013
- Report Date
- April 4, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THIS LEAD WAS CAPPED AND REPLACED BECAUSE DURING A NORMAL DEVICE CHANGE OUT, THE PHYSICIAN FOUND THAT THE LEAD HAD BEEN REPAIRED AT SOME POINT WITH ADHESIVE AND WAS GLUED TO THE HEADER. THE PHYSICIAN TRIED TO ATTACH THE LEAD TO THE NEW DEVICE BUT WAS UNABLE TO GET GOOD NUMBERS SO CAPPED AND REPLACED IT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163520 | KAINOX SL 75/16 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 124218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |