MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-11 for KENTROX SL 65/16 342397 manufactured by Biotronik Gmbh And Co..
[17423544]
From device and mdr. Inappropriate shocks and noise on iegm found to be caused by the pace/sense portion of the icd lead. The pace/sense portion of the lead was capped and a new pace/sense lead was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2006-00163 |
| MDR Report Key | 771472 |
| Report Source | 07 |
| Date Received | 2006-08-11 |
| Date of Report | 2006-08-08 |
| Date of Event | 2006-07-11 |
| Date Mfgr Received | 2006-07-11 |
| Date Added to Maude | 2006-10-23 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN RD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8005470394 |
| Manufacturer G1 | BIOTRONIK, GMBH AND CO |
| Manufacturer Street | * |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENTROX SL 65/16 |
| Generic Name | ICD LEAD |
| Product Code | LTB |
| Date Received | 2006-08-11 |
| Model Number | 342397 |
| Catalog Number | 342397 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 759256 |
| Manufacturer | BIOTRONIK GMBH AND CO. |
| Manufacturer Address | * BERLIN GM |
| Baseline Brand Name | KENTROX SL 65/16 |
| Baseline Generic Name | LEAD |
| Baseline Model No | 342397 |
| Baseline Catalog No | 342397 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-08-11 |