FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY OTW
MDR report key: 3151824
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05612
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- February 28, 2013
- Report Date
- February 6, 2024
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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. CONCOMITANT MEDICAL PRODUCTS: 6935, IMPLANTABLE TACHY LEAD, (B)(6) 2009; 4076, IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD POLARITY WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY 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 |
|---|---|---|---|---|---|---|---|
| 252445 | ATTAIN ABILITY OTW | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P | OJX | MPRI | 419678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention | C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I| C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I |