FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2124059
·
Received June 14, 2011
Report
- Report Number
- 2649622-2011-08048
- Event Type
- Injury
- Date Received
- June 14, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S003
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 THE RIGHT ATRIAL LEAD HAD NOISE. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD HAD AN ACUTE DISLODGEMENT. THE LEAD WAS REPAIRED AND IS STILL IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD BEEN CAPPED A FEW YEARS AGO DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4193 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD |