FDA Adverse Event
Injury
Summary report: N
SPECTRAFLEX
MDR report key: 2813350
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16269
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K790074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 LEAD WAS NOT CAPTURING AND WAS SHOWING SIGNS OF OVERSENSING. AT THE LEAD REVISION, IT WAS NOTED THAT THE LEAD WIRE WAS EXPOSED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRAFLEX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 6971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | ADSR06 IMPLANTABLE PULSE GENERATOR |