MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for INOGEN EL ICD VR D140 manufactured by Boston Scientific Corporation.
[185775111]
It was reported that an alert was observed on this implantable cardioverter defibrillator (icd) system for high out of range shock impedance. Review of device data also indicated there was fine right ventricular (rv) noise observed on a recent ventricular tachycardia (vt) episode. This noise was not oversensed by the icd device. The healthcare provider (hcp) indicated that the patient was subsequently brought into the clinic the following day and all testing performed on the system was normal with no elevated pace impedances or noise observed. The hcp reviewed this information with the electrophysiology (ep), and they are planning to recheck the patient via the remote monitoring system in one (1) month. The products remain in-service. No patient symptoms or adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-03088 |
| MDR Report Key | 9901587 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2016-08-09 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOGEN EL ICD VR |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | LWS |
| Date Received | 2020-03-30 |
| Model Number | D140 |
| Catalog Number | D140 |
| Lot Number | 210620 |
| Device Expiration Date | 2018-08-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |