FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2131557
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10658
- Event Type
- Injury
- Date Received
- June 16, 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
- OH, 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) THE FULL LEAD WAS RETURNED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), AND THE OUTER INSULATION WAS MELTED.
Description of Event or Problem · 1
IT WAS REPORTED THE LEFT VENTRICULAR LEAD HAD HIGH CAPTURE THRESHOLDS. THE LEAD WAS REMOVED 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 | 57 YR | Hospitalization| R | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |