FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3992218
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09990
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 PRODUCT: D314TRG ICD, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAS HIGH THRESHOLDS. THE THRESHOLDS ON THE LEAD HAD INCREASED OVER TIME. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471714 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Hospitalization| R | 6949-65 LEAD, 5076-52 LEAD |