FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 2952408
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00184
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 13, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PATIENT HEARD AN ALERT. THE ALERT WAS NOTED TO HAVE BEEN TRIGGERED DUE TO HIGH IMPEDANCE AND FOR THE DEFIBRILLATION LEAD IMPEDANCE NOT BEING TAKEN. OVERSENSING WAS ALSO NOTED ON THE LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 56365 | TRANSVENE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | RICE CREEK MFG | 6936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |