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 2020-03-31 for ZEPHYR XL DR 5826 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185942469]
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
[185942470]
Patient female, (b)(6) old, (b)(6) kg. Abbott dual-chamber pacemaker was implanted more than 10 years ago due to third-degree atrioventricular block. Recently coming to the hospital for testing, (b)(6) found that the pacemaker battery was about to run out, so he decided to replace the pacemaker. It was replaced on (b)(6), 2020. The pacemaker model was 5826 and the serial number was (b)(4). The patient found that the pacemaker's current consumption was 41 microamperes when the pacemaker programed the patient before discharge from the hospital today. The remaining life of the device is shown as 1. 75-2. 75 years. In the afternoon, i personally tried to adjust the parameters, but the current consumption of the pacemaker was still about 40 microamperes. (b)(6) will perform 5826 replacement surgery on the patient later. The product will be sent to the company for further inspection after it is taken out in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04500 |
| MDR Report Key | 9908492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-08-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ZEPHYR XL DR |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | NVZ |
| Date Received | 2020-03-31 |
| Model Number | 5826 |
| Catalog Number | 5826 |
| Lot Number | P000086315 |
| 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 | 1. Required No Informationntervention | 2020-03-31 |