FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 4162433
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12761
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 8, 2014
- Report Date
- July 11, 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 PRODUCT: 694765 LEAD, IMPLANTED: (B)(6) 2002; 5076-52 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE. THERE WAS A LEAD INTEGRITY WARNING ON THE RIGHT VENTRICULAR (RV) LEAD FOR OVERSENSING AND SHORT INTERVAL COUNTS (SIC). THE LV LEAD WAS PROGRAMMED OFF AND THE RV 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 |
|---|---|---|---|---|---|---|---|
| 639636 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | Required Intervention | D224TRK ICD |