MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-15 for PASSIVE PLUS 1246T/52 SMTFY999 manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi.
[4907260]
It was reported that the right ventricular lead exhibited noise with oversensing. It was clinically resolved by reprogramming. Device remained implanted.
Patient Sequence No: 1, Text Type: D, B5
[11920897]
All info provided by mfr, 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 | 2017865-2014-09014 |
| MDR Report Key | 4054468 |
| Report Source | 07 |
| Date Received | 2014-01-15 |
| Date of Event | 2012-11-29 |
| Date Facility Aware | 2012-11-29 |
| Date Mfgr Received | 2012-11-29 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2014-09-08 |
| 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, CARDIAC RHYTHM MANAGEMENT DIVISI |
| 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 | PASSIVE PLUS |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | DTS |
| Date Received | 2014-01-15 |
| Model Number | 1246T/52 |
| Catalog Number | SMTFY999 |
| Device Expiration Date | 2005-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
| Manufacturer Address | 15900 VALLEY VIEW CT. SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-15 |