MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for QUARTET LEAD SMALL-S, 86 CM 1456Q/86 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185686363]
This product is registered as a combination product. 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
[185686364]
Related manufacturer reference number: 2938836-2020-02336; 2938836-2020-02338; 2938836-2020-02339. It was reported that patient expired. There is no known allegation from a health professional that suggests the death was related to the device. It was reported that the cause of death is unknown.
Patient Sequence No: 1, Text Type: D, B5
[188270437]
A partial lead with the connector pin was returned in one piece. The damage found was sustained during the surgical procedure. The portion of the lead that was returned was otherwise normal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2020-02337 |
| MDR Report Key | 9902847 |
| Report Source | OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-06-21 |
| Date Added to Maude | 2020-03-31 |
| 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 | QUARTET LEAD SMALL-S, 86 CM |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | NIK |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 1456Q/86 |
| Catalog Number | 1456Q/86 |
| Lot Number | A000081775 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Death | 2020-03-31 |