MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-01-13 for TENDRIL ST 1888TC/52 SMTFY999 manufactured by St. Jude Medical, Inc, Crmd.
[4948765]
It was reported that the pt urgently presented in the clinic after receiving inappropriate shocks during the day. Atrial lead exhibited noise. It was resolved by reprogramming the mode to deactivate atrial channel. Device remained implanted.
Patient Sequence No: 1, Text Type: D, B5
[12423859]
All information provided by manufacturer, no medwatch form was received. This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection. There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2014-05801 |
| MDR Report Key | 4139999 |
| Report Source | 05,06,07 |
| Date Received | 2014-01-13 |
| Date of Event | 2011-08-24 |
| Date Facility Aware | 2011-08-24 |
| Date Mfgr Received | 2011-08-24 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2014-10-06 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CARY LAWLER |
| Manufacturer Street | 15900 VALLEY VIEW CT. |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184932621 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC |
| Manufacturer Street | 15900 VALLEY VIEW CT. |
| 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 | TENDRIL ST |
| Generic Name | PERMANENT PACEMAKER ELECTRODE, DTS |
| Product Code | DTS |
| Date Received | 2014-01-13 |
| Model Number | 1888TC/52 |
| Catalog Number | SMTFY999 |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 24 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC, CRMD |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-13 |