FDA Adverse Event
Injury
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 2953098
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00901
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 27, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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. CONCOMITANT PRODUCTS 6945 IMPLANTABLE TACHY LEAD 2002-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED NOT FEELING WELL. IT WAS FOUND THAT THE ATRIAL LEAD WAS OVERSENSING FAR FIELD R AND T WAVES. THE ATRIAL SENSITIVITY WAS ADJUSTED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57186 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6940-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |