FDA Adverse Event
Injury
Summary report: N
ACCENT SR
MDR report key: 3920793
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14396
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND AN INTEGRATED CIRCUIT ANOMALY WHICH CONTRIBUTED TO THE REPORTED BACKUP ANOMALY.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A PATIENT NOTIFIER ALERT. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION AND COULD NOT BE INTERROGATED. ON (B)(6) 2014 THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398420 | ACCENT SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |