FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 1924297
·
Received December 14, 2010
Report
- Report Number
- 2182208-2010-00979
- Event Type
- Injury
- Date Received
- December 14, 2010
- 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
- MT, 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 THERE WAS A LEAD WARNING WITH AN UNDEFINED RESISTANCE. THE CALLER ALSO QUESTIONED VENTRICULAR CAPTURE. THE PATIENT SHOWED SYMPTOMS OF BEING DIZZY AND PASSED OUT. THE LEAD WAS REMOVED 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 | 83 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |