FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 2953325
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00322
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 26, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NOISE ON THE PACE/SENSE 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 |
|---|---|---|---|---|---|---|---|
| 56893 | TRANSVENE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | RICE CREEK MFG | 6936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R | 6933 IMPLANTABLE TACHY LEAD |