FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 4162969
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12506
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: D224TRK ICD, IMPLANTED (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD EARLY BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639261 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | Hospitalization| R | 694765 LEAD, 5076-52 LEAD |