MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-18 for QUADRA ALLURE MP CRT-P PM3562 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[183967245]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[183967247]
It was reported that the patient presented in clinic with phrenic nerve stimulation. The pacemaker was successfully reprogrammed to resolve the nerve stimulation but exhibited some programming anomalies. The message, "vector has not been programmed" was observed on the programmer screen. It was also noted that some menu options were grayed out and were unable to be selected. The investigation of the anomaly was ongoing. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[188149567]
Upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction or caused a serious event. The anomaly was associated with the pulse generator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2020-03804 |
| MDR Report Key | 9849825 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2020-01-11 |
| Date Added to Maude | 2020-03-18 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUADRA ALLURE MP CRT-P |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | NKE |
| Date Received | 2020-03-18 |
| Model Number | PM3562 |
| Catalog Number | PM3562 |
| Lot Number | A000091750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |