MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR 39D-76X manufactured by Stockert Gmbh.
[33103806]
The hardware investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. Concomitant products were used during this study: cr3425ct cable, 39e43r cable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33103807]
It was reported that the impedance reading from ep recording spiked to 4000 when the physician planned to start ablation after mapping in the right atrium during an atrial flutter procedure using a shuttle rf generator (serial number (b)(4)). The impedance cutoff was set to 250 however the generator did not stop delivering rf. The physician was able to stop ablation using the "stop" button on the remote. The procedure was completed successfully without patient consequence. This is reportable as the generator failed to stop ablation once the impedance exceeds cutoff value and thus pose risk to patients.
Patient Sequence No: 1, Text Type: D, B5
[36724652]
Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated. Therefore the following codes apply: (b)(4). It was reported that the impedance reading from ep recording spiked to 4000 when the physician planned to start ablation after mapping in the right atrium during an atrial flutter procedure using a shuttle rf generator ((b)(4)). The impedance cutoff was set to 250 however the generator did not stop delivering rf. The physician was able to stop ablation using the? Stop? Button on the remote. Repair follow-up was performed and device will not shipped for service. Service was declined. Complaint was unable to confirm. It was informed that device was working fine. The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.
Patient Sequence No: 1, Text Type: N, H10
[48104615]
This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612355-2015-00059 |
| MDR Report Key | 5271504 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-08 |
| Date of Event | 2015-11-08 |
| Date Mfgr Received | 2015-11-08 |
| Device Manufacturer Date | 2003-07-31 |
| Date Added to Maude | 2015-12-07 |
| 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 | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | STOCKERT GMBH |
| Manufacturer Street | BOETZINGER STRASSE 72 |
| Manufacturer City | FREIBURG, B-W D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR |
| Generic Name | SIMILAR DEVICE S7001, PMA # P990071 |
| Product Code | BXN |
| Date Received | 2015-12-07 |
| Model Number | 39D-76X |
| Catalog Number | 39D-76X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STOCKERT GMBH |
| Manufacturer Address | BOETZINGER STRASSE 72 FREIBURG, B-W D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-07 |