FDA Adverse Event
Injury
Summary report: N
ASSURITY PLUS
MDR report key: 8756207
·
Received July 2, 2019
Report
- Report Number
- 2938836-2019-05461
- Event Type
- Injury
- Date Received
- July 2, 2019
- Date of Event
- November 16, 2016
- Report Date
- July 2, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWP
- UDI-DI
- 05414734507080
- PMA / PMN Number
- P970013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 07/02/2019 UNDER AUTHORIZATION NUMBER E19974033 FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4). ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 07/02/2019 UNDER AUTHORIZATION NUMBER E19974033 FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549068 | ASSURITY PLUS | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | PM1260 | S000016725 | 05414734507080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |