FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 1925591
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13949
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- October 8, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID ON DISTAL CONDUCTOR(NOT OBSTRUCTED).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE LEFT VENTRICULAR LEAD HAD MUSCLE/NERVE STIMULATION. THE LEAD WAS REPLACED WITH SMALLER LEAD. NO PATIENT COMPLICATIONS WERE 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. | 4194 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |