FDA Adverse Event
Injury
Summary report: N
ZEPHYR XL SR
MDR report key: 9521998
·
Received December 26, 2019
Report
- Report Number
- 2938836-2019-17373
- Event Type
- Injury
- Date Received
- December 26, 2019
- Report Date
- April 23, 2020
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVZ
- UDI-DI
- 05414734501712
- PMA / PMN Number
- P880086
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-17679. IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL ON (B)(6) 2019 DUE TO THE DEVICE BEING DAMAGED AND EXPOSED. INFECTION WAS SUSPECTED BUT NOT CONFIRMED. THE CAUSE OF THE POCKET EROSION AND INFECTION IS UNKNOWN. THE PACEMAKER AND LEAD WERE EXPLANTED ON (B)(6) 2019 AND A NEW SYSTEM WAS IMPLANTED ON (B)(6) 2019. THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313386 | ZEPHYR XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | NVZ | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 5626 | P000069331 | 05414734501712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |