FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS VR
MDR report key: 1954734
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00456
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 10, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT WAS DELIVERED FOR OUT OF RANGE IMPEDANCE. IT WAS SUSPECTED THAT THE HIGH IMPEDANCES COULD BE AN IMPROPER CONNECTION OF THE SVC LEAD OR LEAD DAMAGE. THE COMPETITOR LEAD WAS USED FOR DEFIB AND SJM LEAD WAS BEING USED FOR SENSE/PACE. THE COMPETITOR LEAD WAS EXPLANTED. THE SJM LEAD AND ICD MEASURED NORMAL IMPEDANCE VALUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |