FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR ICD
MDR report key: 5091354
·
Received September 21, 2015
Report
- Report Number
- 2938836-2015-29873
- Event Type
- Injury
- Date Received
- September 21, 2015
- Date of Event
- August 11, 2015
- Report Date
- August 11, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CODE AVAILABLE. FINAL ANALYSIS FOUND THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN INTERNAL CAPACITOR ANOMALY WAS FOUND. THE ROOT CAUSE OF THE EXTENDED CHARGE TIME WAS AN INTERNAL HV CAPACITOR ANOMALY.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED TO THE ER AFTER RECEIVING A PATIENT NOTIFIER. INTERROGATION REVEALED A MESSAGE INDICATING THE CHARGE TIME LIMIT WAS REACHED. AN IN-CLINIC CAPACITOR MAINTENANCE PERFORMANCE RESULTED IN A CHARGE TIME TIMEOUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623201 | ELLIPSE DR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2311-36 | 3841702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |