FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 3993031
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09530
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- March 31, 2014
- Report Date
- June 27, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. CONCOMITANT PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2014; 6935M62 LEAD IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE AND DIAPHRAGMATIC STIMULATION RELATED TO LEFT VENTRICULAR (LV) LEAD PACING. THE STIMULATION WAS REPORTED TO BE RESOLVED BY REPROGRAMMING THE LV LEAD OUTPUT. THE LEAD REMAINS IN USE. THE PATIENT WAS REPORTED TO BE ENROLLED IN THE PANORAMA II CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472729 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention | DTBA2QQ CRT-D |