FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2200568
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11021
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- 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. EVALUATION SUMMARY: (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE DEVICE LONGEVITY WAS LESS THAN THREE YEARS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD (LV) THRESHOLD WAS HIGH AND THE LV OUTPUT WAS HIGH. THE DEVICE WAS REPLACED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4194 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD |