FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 6009258
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-13360
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- July 6, 2016
- Report Date
- July 7, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION POST-OPERATIVELY. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE PHRENIC NERVE STIMULATION INTERMITTENTLY THROUGHOUT THE NIGHT. ELEVATED THRESHOLDS WERE NOTED. THE LV LEAD WAS TURNED OFF AND A CHEST X-RAY WAS PERFORMED. THE LV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656596 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R | DTBA1QQ CRT-D, 5076-52 LEAD, 6935M62 LEAD |