MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-14 for CLEARSIGN? AMPLIFIER M00420012530 2001253 manufactured by Boston Scientific - Fremont (ce).
[94953593]
Device evaluated by manufacturer - the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94953594]
Same case as mfr id # 2134265-2017-12133. It was reported that incorrect pacing occurred. It was reported that during an electrophysiology procedure involving an lspro and a non-bsc simulator, pacing was delivered to the atrium; however, pacing was also delivered to the ventricle though a secondary catheter located in the ventricle. The physician was only able to resolve the secondary pacing by physically unplugging the catheter that was located in the ventricle in order to only pace the atrium. It was suspected that the cable may have been internally damaged; however no visual damage was observed. No patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-12128 |
| MDR Report Key | 7117288 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-14 |
| Date of Report | 2017-11-18 |
| Date Mfgr Received | 2017-11-18 |
| Date Added to Maude | 2017-12-14 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - FREMONT (CE) |
| Manufacturer Street | 47215 LAKEVIEW BLVD NORTH DOCK |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARSIGN? AMPLIFIER |
| Generic Name | AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL |
| Product Code | DRQ |
| Date Received | 2017-12-14 |
| Model Number | M00420012530 |
| Catalog Number | 2001253 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - FREMONT (CE) |
| Manufacturer Address | 47215 LAKEVIEW BLVD NORTH DOCK FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-14 |