FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR
MDR report key: 2242429
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06547
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 23, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE ANOMALY REPORTED IN THE FIELD WAS CONFIRMED. DEVICE SENSING WAS NORMAL. THE DEVICE WAS TESTED IN OUR AUTOMATED TESTING EQUIPMENT. THE HV OUTPUT CIRCUITRY WAS FOUND DAMAGED DUE TO A LEAD ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER AFTER RECEIVING HV THERAPY. INTERROGATION FOUND AN ALERT FOR POSSIBLE HIGH VOLTAGE CIRCUIT DAMAGE WAS RECEIVED. LOW IMPEDANCE WAS OBSERVED AND CAPACITOR MAINTENANCE COULD NOT BE COMPLETED. HV THERAPY UNAVAILABLE. LEAD FRACTURE SUSPECTED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 1580/65, (B)(4) |