FDA Adverse Event
Injury
Summary report: N
INTEGRITY DR
MDR report key: 3923122
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14463
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 2, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS CONFIRMED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR A FOLLOW-UP AND THE PULSE GENERATOR WAS FOUND IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401773 | INTEGRITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5366 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |