MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-05 for LINOX SMART SD 65/16 359066 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[3285963]
This lead became dislodged and was causing diaphragmatic stimulation. One day post implant, the physician attempted to reposition this lead, but a stylet could not be fully inserted into the lead body. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
[20410631]
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. The inspection demonstrated deformations of the inner coil close to the is-1 connector pin. The subsequent destructive analysis indicated that these damages were caused by over rotation of the inner coil without a completely inserted stylet. Furthermore, cuttings in the insulation were found, which originated most likely from the explant procedure. No further deviations were noted which might be related to the clinical observation as mentioned in the complaint description. No sign of a material or manufacturing problem was present.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2013-00172 |
| MDR Report Key | 2953908 |
| Report Source | 05,07 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-01-21 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2013-07-26 |
| Device Manufacturer Date | 2012-06-08 |
| Date Added to Maude | 2013-02-12 |
| 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 SMART SD 65/16 |
| Generic Name | ICD LEAD |
| Product Code | DTA |
| Date Received | 2013-02-05 |
| Returned To Mfg | 2013-01-22 |
| Model Number | 359066 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-02-05 |