FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 1874680
·
Received October 19, 2010
Report
- Report Number
- 2649622-2010-11506
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 16, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. ALL CONDUCTORS DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED). OUTER INSULATION MELTED. FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD POSITIONING/FIXATION DIFFICULTY. 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 ABILITY | IMPLANTABLE PACING LEAD | OJX | MEDTRONIC PUERTO RICO, INC. | 4196 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 5076 (X2) IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR |