FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 3920390
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14011
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- May 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0298
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT A TRANSTELEPHONIC MONITORING CHECK OF THE PULSE GENERATOR INDICATED NO MAGNET RATE RESPONSE. IT WAS SUSPECTED THAT THE DEVICE WAS IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397398 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |