FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2964695
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01921
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- November 28, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN IMPEDANCE ISSUE AND THE RIGHT ATRIAL LEAD WAS OVERSENSING. BOTH LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66523 | CAPSUREFIX | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |