MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-01-28 for CLEARSIGN? AMPLIFIER H30120019680 2001968 manufactured by Boston Scientific - Lowell, Ma.
[22032022]
Same case as mdr 2134265-2015-00348. It was reported that unintended rf energy was delivered to the patient. During an ablation procedure, 10hz noise was seen on the ablation channel when no rf energy was applied. Somehow there was pacing captured in the atrium for the ablation catheter (10hz), indicating the ablation catheter was sending energy into the patient. No patient complications were reported and the patient is in good condition. No additional treatment was required.
Patient Sequence No: 1, Text Type: D, B5
[22225897]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30737064]
Device evaluated by mfr: the results of the testing indicated that the returned carto cable as well as the associated clearsign amplifier passed incoming inspection tests, including noise and leakage testing. The cable shielding connection was verified by measuring the capacitance and impedance and results were similar to the control cable. The possibility of interaction effects between the two components as a cause was eliminated by testing the returned complaint amplifier and cable together and found no issues. Both devices performed as expected. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable cause of the reported difficulties may be due interaction with another device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30737225]
Same case as mdr 2134265-2015-00348. It was reported that unintended rf energy was delivered to the patient. During an ablation procedure, 10hz noise was seen on the ablation channel when no rf energy was applied. Somehow there was pacing captured in the atrium for the ablation catheter (10hz), indicating the ablation catheter was sending energy into the patient. No patient complications were reported and the patient is in good condition. No additional treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2015-00590 |
| MDR Report Key | 4461056 |
| Report Source | 01,05,07 |
| Date Received | 2015-01-28 |
| Date of Report | 2014-12-30 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2015-04-06 |
| Date Added to Maude | 2015-01-28 |
| 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 Contact | EMP. LINDA LEIMER |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - LOWELL, MA |
| Manufacturer Street | 55 TECHNOLOGY DRIVE |
| Manufacturer City | LOWELL MN 01851 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01851 |
| 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 | 2015-01-28 |
| Returned To Mfg | 2015-01-19 |
| Model Number | H30120019680 |
| Catalog Number | 2001968 |
| Lot Number | EPVI0094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - LOWELL, MA |
| Manufacturer Address | 55 TECHNOLOGY DRIVE LOWELL MN 01851 US 01851 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-28 |