FDA Adverse Event
Injury
Summary report: N
CUSTOM PACING LEAD
MDR report key: 3991702
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02112
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: 4965-35 LEAD IMPLANTED: 1996-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) EPICARDIAL LEAD WAS CAPPED DUE TO HIGH IMPEDANCE. THE LEAD IS SUSPECT OF A POSSIBLE FRACTURE. THE LEAD WAS NOT REPLACED AND REMAINS OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468152 | CUSTOM PACING LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, INC. | 10295B35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00023 YR | Hospitalization| R | E2DR01AA IPG |