FDA Adverse Event
Injury
Summary report: N
ZEPHYR XL SR
MDR report key: 5982176
·
Received September 27, 2016
Report
- Report Number
- 2017865-2016-06278
- Event Type
- Injury
- Date Received
- September 27, 2016
- Date of Event
- August 23, 2016
- Report Date
- July 27, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
NEW INFORMATION ON 4/27/17 STATED THAT THE PULSE GENERATOR WAS EXPLANTED AND REPLACED ON (B)(6) 2017. NO FURTHER INFORMATION WAS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. ALL ELECTRICAL MEASUREMENTS WERE IN RANGE. NO INTERVENTION WAS PERFORMED. THE PATIENT WOULD CONTINUE TO BE MONITORED CLOSELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632131 | ZEPHYR XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 5626 | 0002135109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |