FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3051871
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04740
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- February 18, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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: 6949 IMPLANTABLE TACHY LEAD: (B)(6) 2006. 5076 IMPLANTABLE PACING LEAD: (B)(6) 2006. 7299 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD): (B)(6) 2006. (B)(4). (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE, THE PHYSICIAN DISLODGED BOTH THE RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD. THE RA AND LV LEADS WERE EXPLANTED AND REPLACED WITH NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153567 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention |