FDA Adverse Event
Injury
Summary report: N
ATTAIN LV
MDR report key: 3993819
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09107
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- January 1, 2010
- Report Date
- June 23, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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: D274TRK ICD, IMPLANTED: (B)(6) 2010; 6949-65 LEAD, IMPLANTED: (B)(6) 2005; 310F29 TISSUE VALVE, IMPLANTED: (B)(6) 2004. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED AND LATER CAPPED DUE TO DIAPHRAGMATIC STIMULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470899 | ATTAIN LV | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 2187-75 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | 5076-52 LEAD |