FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS LEAD
MDR report key: 3991322
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02157
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- January 16, 2006
- Report Date
- May 6, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- K883743
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 5024M-52 LEAD: (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NOISE/OVERSENSING ON THE ATRIAL LEAD. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467432 | TRANSVENOUS LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, INC. | 4058M52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R | E2DR03AA IPG |