SCREW-IN
Report
- Report Number
- 2649622-2012-15100
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 AND THE DEVICE MET EXPECTED LONGEVITY. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK OCCURRED ON (B)(4) 2012 WITH DEVICE RRT <=2.6251 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.632 TO 2.618 VOLTS BETWEEN (B)(4) 2012. A PATIENT ALERT FOR LOW BATTERY VOLTAGE OCCURRED ON (B)(4) 2012 02:15:00. (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND.
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) REACHED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). THE LV LEAD AND ICD WERE 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 |
|---|---|---|---|---|---|---|---|
| 1 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | 1688TC COMPETITOR IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD |