MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-30 for ZEPHYR DR 5820 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185687175]
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
[185687176]
It was reported that during device check at distributor's sales office in a non-clinical environment, the pacemaker exhibited battery impedance out of recommendation range. The device was checked multiple times but the battery impedance values were out of recommended range. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[188753068]
A pacemaker was returned for the reported event of high battery impedance. As received, the device was above normal elective replacement indicator (eri). Electrical testing found no anomalies. The reported event was confirmed and attributed to the local temperature the device was soaked at prior to interrogation, indicating no malfunction or device problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2020-04387 |
| MDR Report Key | 9900517 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2020-03-30 |
| 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 | ZEPHYR DR |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | NVZ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-23 |
| Model Number | 5820 |
| Catalog Number | 5820 |
| Lot Number | 6855390 |
| 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-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |