MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-19 for LINOX SD 65/16 350053 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[3298919]
This lead was capped and replaced due to high impedances and high thresholds. There were no adverse pt events reported. Should additional information be received, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
[10635983]
The device was not returned for analysis. The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device. The manufacturing process for this device was re-investigated. All production steps had been performed accordingly. There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation. In summary, the device was not returned for analysis. The review of the quality documents confirmed a regular device manufacturing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2013-00384 |
| MDR Report Key | 3004025 |
| Report Source | 05,07 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2013-03-20 |
| Device Manufacturer Date | 2007-05-11 |
| Date Added to Maude | 2013-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Manufacturer G1 | BIOTRONIK SE & CO. KG |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINOX SD 65/16 |
| Generic Name | ICD LEAD |
| Product Code | LSW |
| Date Received | 2013-02-19 |
| Model Number | 350053 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-02-19 |