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 TENDRIL STS 2088TC/58 2088TC-58 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185693892]
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
[185693893]
Related manufacturer reference number: 2938836-2020-02336; 2938836-2020-02337;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
[188142029]
A partial lead with the connector pin was returned in one piece measuring 6. 6 cm. 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 | 2938836-2020-02338 |
| MDR Report Key | 9902860 |
| Report Source | OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-06-07 |
| 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 | TENDRIL STS |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | NVN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 2088TC/58 |
| Catalog Number | 2088TC-58 |
| Lot Number | S000071018 |
| 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 |