FDA Adverse Event
Injury
Summary report: N
TRANSVENE RV
MDR report key: 3991446
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02147
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 9, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 MEDICAL PRODUCTS: A 693335 LEAD IMPLANTED: (B)(6) 1995. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD COIL TO THE RING ELECTRODE WAS TESTED AND THE CURRENT WAS HIGH DUE TO INSULATION DAMAGE. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 470173 | TRANSVENE RV | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC, INC. | 6936-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R | D154VWC ICD |