FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 6161347
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-14419
- Event Type
- Injury
- Date Received
- December 9, 2016
- Date of Event
- September 7, 2016
- Report Date
- September 7, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- UDI-DI
- 00643169601840
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 IS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR LEAD. THE LEAD HAS BEEN REPROGRAMMED TO SEVERAL DIFFERENT VECTORS AND THE STIMULATION HAS CONTINUED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 811900 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 439878 | 00643169601840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | DTMC1QQ ICD, 6935M62 LEAD, 5076-52 LEAD |