ATTAIN ABILITY
Report
- Report Number
- 2649622-2010-12440
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 AND ANALYZED. PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES. ANALYSIS ALSO REVEALED THAT THE CONDUCTORS WERE DISTORTED, BLOOD/BODY FLUIDS IN ALL THE CONDUCTORS (NOT OBSTRUCTED), AND APPARENT EXPLANT DAMAGE. (B)(4) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE LEAD DISLODGED, THERE WERE UNACCEPTABLE THRESHOLDS AND OVERSENSING OBSERVED. THE PATIENT ANATOMY WAS TORTUOUS AND ATTEMPTS TO REVISE WERE UNSUCCESSFUL. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR PREMATURELY. THE DEVICE 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 ABILITY | IMPLANTABLE PACING LEAD | OJX | MEDTRONIC PUERTO RICO, INC. | 4196 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |