FDA Adverse Event
Injury
Summary report: N
TBD
MDR report key: 2955443
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01429
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 11, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089/S038
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 DEVICE WAS PROGRAMMED TO AAI DUE TO FAR FIELD R-WAVES (FFRW) ON THE ATRIAL LEAD. WHEN THE DEVICE WAS PROGRAMMED TO AAI POCKET STIMULATION WAS SEEN AND LOW IMPEDANCE READINGS HAVE BEEN NOTED. THE DEVICE WAS REPROGRAMMED TO DECREASE THE VOLTAGE, STIMULATION WENT AWAY, AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59006 | TBD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5592-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention | 6947 IMPLANTABLE TACHY LEAD |