MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for AV PLUS DX BIFUR BIPOLAR LEAD 1368/58 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[184634045]
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
[184634046]
Related manufacturer reference number: 2017865-2020-03139. It was reported that patient presented to follow up on (b)(6) 2020 with his own junctional rhythm and experiencing fatigue. Upon interrogation, the pacemaker exhibited no pacing on electrograms. The battery longevity had significantly dropped since last follow up on (b)(6) 2019, premature battery depletion was suspected. The device was explanted and replaced. On (b)(6) 2020, during the procedure, the right ventricular lead exhibited high impedance and failure to capture in bipolar configuration. The lead was reprogrammed to unipolar configuration. Patient was stable during and after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-03521 |
| MDR Report Key | 9869515 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2011-11-11 |
| Date Added to Maude | 2020-03-23 |
| 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-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| 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 | AV PLUS DX BIFUR BIPOLAR LEAD |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | DXY |
| Date Received | 2020-03-23 |
| Model Number | 1368/58 |
| Lot Number | 3547136 |
| Device Expiration Date | 2014-11-30 |
| 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-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |