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 2019-11-27 for QUADRA ASSURA MP ICD CD3369-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).
[168429652]
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. The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[168429653]
Manufacturer report number: 2017865-2019-17145. It was reported that the patient presented in clinic for follow up. Upon review, it was revealed that the patient experienced unresolved chronic pain at the left pectoral pulse generator site and left shoulder. There were reportedly complaints of intermittent phrenic nerve stimulation as well. Programming changes were made to deactivate the left ventricular lead. The patient presented for revision procedure. During procedure, the left ventricular lead was deemed sub-optimally positioned due to the patient? S complaints of sporadic phrenic nerve stimulation. The left ventricular lead and implantable cardioverter defibrillator was explanted and replaced on (b)(6) 2019. No pocket abnormalities were noted and no device malfunctions were inferred. The patient was stable before, during, and after the procedure.
Patient Sequence No: 1, Text Type: D, B5
[181488244]
Analysis was normal. No anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2019-17226 |
| MDR Report Key | 9387670 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2019-11-27 |
| 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 ASSURA MP ICD |
| Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | NIK |
| Date Received | 2019-11-27 |
| Model Number | CD3369-40Q |
| Catalog Number | CD3369-40Q |
| Lot Number | A000082257 |
| 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 | 1. Required No Informationntervention | 2019-11-27 |