FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 3860005
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-05634
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 6, 2014
- Report Date
- March 6, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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. CONCOMITANT PRODUCTS: 4568-45 LEAD, (B)(6) 2003; 6947-65 LEAD, (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD SHOWED ELEVATED THRESHOLDS WHICH CONTRIBUTED TO THE SHORTENED DEVICE LIFE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LV 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 |
|---|---|---|---|---|---|---|---|
| 341725 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | Hospitalization| R | D274TRK ICD |