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 INTERVENE LEAD 497-23-70 manufactured by Boston Scientific Corporation.
[186305769]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186305770]
It was reported that this patient was in a motor vehicle accident (mva). After the mva, the right ventricular (rv) lead exhibited high out-of-range (oor) shock impedances. The patient also had a subcutaneous defibrillation patch. Fluoroscopy was performed, and the subcutaneous defibrillation patch was fractured, and had damage to the terminal end and lead body. In addition, the rv lead had damage to the terminal end, and was also fractured. Subsequently, a revision procedure was performed. The subcutaneous defibrillation patch and rv lead were surgically abandoned, and a new lead was successfully implanted. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-03206 |
| MDR Report Key | 9901719 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-27 |
| 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 |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 551125798 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551125798 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERVENE LEAD |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | LWS |
| Date Received | 2020-03-30 |
| Model Number | 497-23-70 |
| Device Expiration Date | 2003-08-01 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |