FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 1991876
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02600
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- December 1, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Adverse Event
- 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) THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE 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 | 76 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |