FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 2063550
·
Received April 19, 2011
Report
- Report Number
- 2182208-2011-00643
- Event Type
- Injury
- Date Received
- April 19, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COMPLAINTS OF "SLUMPING OVER". IT WAS FURTHER REPORTED THAT LOSS OF CAPTURE AND OVERSENSING WERE PRESENT. HIGH IMPEDANCE WAS ALSO PRESENT WITH POSITION CHANGES. THE LEAD HAS BEEN CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE EPI | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 4965 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization| L| R | SESR01 IMPLANTABLE PULSE GENERATOR |