FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 3920469
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14067
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 13, 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
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS CONFIRMED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
A MANDATORY MEDWATCH FORM WAS RECEIVED (B)(4) 2014, THE USER FACILITY NUMBER IS (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE HOSPITAL FOR A PULSE GENERATOR REPLACEMENT. THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE DEVICE WAS SUCCESSFULLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396583 | IDENTITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5380 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |