FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 1862995
·
Received October 9, 2010
Report
- Report Number
- 2649622-2010-11378
- Event Type
- Injury
- Date Received
- October 9, 2010
- Date of Event
- August 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE BLOOD/BODY FLUID OBSERVED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A RECENT GENERATOR CHANGE AND NOW THE PATIENT HAS A LARGE POCKET HEMATOMA. PRIOR TO THE GENERATOR CHANGE OUT, THE LV THRESHOLDS WERE LOW AND NOW THEY ARE HIGH WITH INTERMITTENT CAPTURE. IT WAS FURTHER REPORTED THAT THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. 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 | 46 YR | Required Intervention | 0085 NON-MEDTRONIC IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |