FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS DR
MDR report key: 3588366
·
Received January 22, 2014
Report
- Report Number
- 2938836-2014-06585
- Event Type
- Malfunction
- Date Received
- January 22, 2014
- Date of Event
- January 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF DIFFICULTY REMOVING THE RV LEAD WAS NOT VERIFIED IN THE LABORATORY. UPON RECEIPT, THE V IS-1 BI SEPTA AND SET SCREWS WERE NOT RETURNED WITH THE DEVICE. THE DIAMETERS OF THE ATRIAL AND VENTRICULAR IS-1 BI LEAD BORES WERE MEASURED USING PIN GAUGES AND WERE FOUND TO BE WITHIN SPECIFICATION. TEST SET SCREWS WERE USED AND TEST LEADS INSERTED AND SECURED PROPERLY TO THE HEADER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, THE PIN ON THE RV LEAD WOULD NOT RELEASE FROM THE DEVICE HEADER DESPITE THE SET SCREWS BEING REMOVED. THE LEAD WAS FREED ONCE SURROUNDING TISSUE WAS REMOVED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52336 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |