FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 6008989
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-13222
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- July 26, 2016
- Report Date
- August 16, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 A FEW HOURS POST IMPLANT, THE PATIENT SUFFERED FROM CONSTANT PHRENIC NERVE STIMULATION DUE TO THE LEFT VENTRICULAR (LV) LEAD. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN (B)(6). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656528 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | 6947M62 LEAD, 5076-52 LEAD, DTMB1QQ ICD |