FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 1924205
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13461
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- August 9, 2010
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS TURNED BACK ON AND IS CURRENTLY CAPTURING. THE PATIENT IS PART OF THE (B)(6) STUDY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD SUSTAINED AND INTERMITTENT FAILURE TO CAPTURE. THE LEAD WAS ELECTRICALLY ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 4194 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |