FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 2790905
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-15383
- Event Type
- Injury
- Date Received
- October 15, 2012
- Date of Event
- August 13, 2012
- Report Date
- September 2, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006/S002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. THE LEAD WAS INACTIVATED AND SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY (SLS). NO FURTHER 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 PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MEDTRONIC PUERTO RICO, INC. | 4296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 6947M IMPLANTABLE TACHY LEAD| D314TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D314TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947M IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |