FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3991577
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08031
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 5, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 MEDICAL PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2005; 694958, LEAD, IMPLANTED: (B)(6) 2005; C154DWK, ICD, IMPLANTED: (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING HIGH THRESHOLDS. AN ATTEMPT WAS MADE TO REPLACE THE LEAD, BUT ACUTE BIFURCATIONS IN THE PATIENT¿S CORONARY VEIN VESSELS OBSTRUCTED THE AREA. THE CHRONIC 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 |
|---|---|---|---|---|---|---|---|
| 470501 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R | 383069 LEAD (B)(6) 2009 |