FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3153336
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05957
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 CONTINUED: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2013; 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2003; 694765 IMPLANTABLE TACHY LEAD (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD CAUSED DIAPHRAGMATIC STIMULATION AND HAD HIGH OUTPUTS IN ALL CONFIGURATIONS. THE LEAD WAS EXPLANTED AND WAS 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 |
|---|---|---|---|---|---|---|---|
| 255232 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |