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 2020-03-31 for TENDRIL STS 2088TC/46 2088TC-46 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185744277]
This product is registered as a combination product. 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
[185744278]
Related manufacturer reference number: 2938836-2020-02342, 2938836-2020-02345. It was reported that the patient presented in clinic for device and lead change out procedure. Noise oversensing was observed on the right atrial (ra) lead. The noise was reproduced with any types of patient movements. Due to the patient advanced age and not being candidate for lead explant, the lead was capped on (b)(6) 2020. During the procedure, lead helix damage was observed on the new ra lead. The lead could no longer extend. The lead was cut, and a new sheath was slide over the lead to regain access. The new lead was implanted successfully. The patient was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02343 |
| MDR Report Key | 9904194 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2020-01-19 |
| 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 |
| Model Number | 2088TC/46 |
| Catalog Number | 2088TC-46 |
| Lot Number | P000097199 |
| 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 | 2020-03-31 |