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 2020-03-17 for IDENTITY ADX XL DR 5386 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[183758471]
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
[183758472]
It was reported that during a device change out due to end of life (eol), the right ventricular lead would not be loosen from the pacemaker' s header. While replacing the new lead, the patient became too restless so the procedure was abandoned. The patient was later brought back to the lab to explant the device. The new device was implanted on the left side. The patient was stable before, during and after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-01848 |
| MDR Report Key | 9843167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2006-08-08 |
| Date Added to Maude | 2020-03-17 |
| 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 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 | IDENTITY ADX XL DR |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | DXY |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 5386 |
| Catalog Number | 5386 |
| Lot Number | 0002226346 |
| Device Expiration Date | 2008-02-29 |
| 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. Required No Informationntervention | 2020-03-17 |