FDA Adverse Event
Malfunction
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 2952169
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00490
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S091
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE LEAD SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO ATTEMPTED IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD IT WAS NOTED TO HAVE A HELIX MALFUNCTION ISSUE WHEREBY THE HELIX "WAS NOT COMING OUT SMOOTHLY." THEREFORE, THE RV LEAD WAS NOT USED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55909 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |