FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF PACEMAKER
MDR report key: 5140578
·
Received October 9, 2015
Report
- Report Number
- 2017865-2015-28472
- Event Type
- Injury
- Date Received
- October 9, 2015
- Date of Event
- September 1, 2015
- Report Date
- September 1, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- PMA / PMN Number
- P030035
- Removal / Correction Number
- Z0429
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
NO CONCLUSION CODE AVAILABLE. FINAL ANALYSIS FOUND THAT THE COMPLAINT OF PREMATURE ELECTIVE REPLACEMENT INDICATOR WAS CONFIRMED. SUDDEN VOLTAGE DROP WAS RECORDED IN THE DEVICE IMAGE. THE CAUSE OF THE PREMATURE ERI WAS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF EXPERIENCING LOW HEART RATE AND WAS BROUGHT TO THE CLINIC. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2015. THE PATIENT'S CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671728 | ACCENT DR RF PACEMAKER | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | PM2210 | 2830692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |