FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2201356
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11104
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 5, 2011
- 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
- AR, 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. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON ALL CONDUCTORS (NOT OBSTRUCTED).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD PHRENIC NERVE STIMULATION AND HIGH THRESHOLDS DURING THE ATTEMPTED IMPLANT. THE LEAD WAS REMOVED AND REPLACED BY A NEW LEAD. NO 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 | 66 YR | Other |