MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for VALITUDE X4 CRT-P U128 manufactured by Boston Scientific Corporation.
[186166950]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186166951]
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system oversensed noise on the patient's non-boston scientific right ventricular (rv) lead, which resulted in pacing inhibition. The patient experienced greater than two seconds of asystole. Subsequently, a revision procedure was performed, and the rv lead was explanted and replaced. The crt-p remains in service. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-01205 |
| MDR Report Key | 9886687 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2017-07-11 |
| Date Added to Maude | 2020-03-26 |
| 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 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 | VALITUDE X4 CRT-P |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
| Product Code | NKE |
| Date Received | 2020-03-26 |
| Model Number | U128 |
| Catalog Number | U128 |
| Lot Number | 722508 |
| Device Expiration Date | 2019-06-21 |
| 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 | 2020-03-26 |