MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for INOGEN EL ICD DR D142 manufactured by Boston Scientific Corporation.
[185756373]
It was reported that the patient received anti-tachycardia pacing (atp) and shock therapy from this implantable cardioverter defibrillator (icd) device. Information indicates this therapy was inappropriate as it was provided due to an atrial-driven arrhythmia. Device therapy was exhausted, and the patients rhythm never broke. Boston scientific technical services provided guidance to the boston scientific representative on possible device programming changes or to possibly consider use of rate control medications. The device remains in-service. No patient symptoms or adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-03595 |
| MDR Report Key | 9901571 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2017-12-14 |
| 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 |
| 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 CLONMEL LIMITED |
| 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 DR |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | LWS |
| Date Received | 2020-03-30 |
| Model Number | D142 |
| Catalog Number | D142 |
| Lot Number | 538875 |
| Device Expiration Date | 2019-11-17 |
| 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 |