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 VALITUDE CRT-P U125 manufactured by Boston Scientific Corporation.
[185747980]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185747981]
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and a non boston scientific right ventricular (rv) lead exhibited impedance measurements of greater than 2000 ohms, and left ventricular (lv) impedance measurements of greater than 2000 ohms, triggering a lead safety switch (lss). After the lss, rv noise, oversensing, and pacing inhibition with less than two seconds of asystole was observed. Increased noise was reproduced with patient isometrics. The device was reprogrammed. Also, right atrial (ra) oversensing of rv signals was noted. Further troubleshooting and programming options were discussed. No adverse patient effects were reported. The device remains in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-02348 |
| MDR Report Key | 9901624 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-06-14 |
| 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 CORPORATION |
| 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 | VALITUDE CRT-P |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | NKE |
| Date Received | 2020-03-30 |
| Model Number | U125 |
| Catalog Number | U125 |
| Lot Number | 709527 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 |