FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS VR, DF4 CONNECTOR
MDR report key: 3101116
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01903
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 27, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT INAPPROPRIATE THERAPY WAS DELIVERED TO THE PATIENT BY THE DEVICE. REPROGRAMMING WAS SUGGESTED. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT CONTINUED RECEIVING SHOCKS ON A FREQUENT BASIS AND THE DEVICE THEN STOPPED WORKING. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203415 | CURRENT PLUS VR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD1211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |