FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 3153378
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05973
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN DID NOT LIKE THE WAY THE LEFT VENTRICULAR (LV) LEAD WAS MOVING BACK UPON WITHDRAWING THE SHEATH. THE LV LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258895 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |