MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-22 for QUADRA ALLURE MP CRT-P PM3562 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[184414025]
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
[184414026]
It was reported that patient complained of soreness and redness at implant site, and a pocket infection was suspected. The patient was brought to the electrophysiology lab, and the whole system was explanted and discarded. The patient was stable before, during and after the procedure. The system will not be return for evaluation. There was no allegation against the devices or leads. The patient had a history of prior competitor pacemaker infection in 2019. Related manufacturer reference number: 2938836-2020-02096 and 2938836-2020-02097.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02095 |
| MDR Report Key | 9863864 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-22 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-03-22 |
| 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-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| 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 | 2020-03-22 |
| Model Number | PM3562 |
| Catalog Number | PM3562 |
| Lot Number | P000086249 |
| 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-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-22 |