FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 1921229
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12403
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S003
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED DISTAL CONDUCTOR BLOOD/BODY FLUD (NOT OBSTRUCTED).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD PULLED BACK OUT OF THE CORONARY SINUS. THE LEAD WAS EXPLANTED 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 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4193 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 6949 IMPLANTABLE TACHY LEAD| 4592 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |