FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3153411
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06002
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 20, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. (B)(4) COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2005; 0145 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2000. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS FOUND TO HAVE DISLODGED FROM THE ORIGINAL BRANCH IT WAS POSITIONED IN. THE LEAD HAD PULLED BACK INTO THE MAIN CORONARY SINUS. THE LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256922 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | UNK COMPETITOR PACEMAKER |