FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 4161782
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11412
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- June 30, 2014
- Report Date
- August 7, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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: 694765 LEAD, IMPLANTED: (B)(6) 2010; 407652 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING FREQUENT, BUT MANAGEABLE, PHRENIC STIMULATION DUE TO THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639708 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Required Intervention | D224TRK ICD |