FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3861205
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07343
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 5, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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: D314TRG ICD, IMPLANTED: (B)(6) 2012; 1688T LEAD, IMPLANTED: (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS AND MAY HAVE CONTRIBUTED TO THE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340729 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 4193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R | 6947-65 LEAD |