ENTRUST AT
Report
- Report Number
- 6000144-2010-03387
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- Z-1172-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND VARYING RESISTANCE/IMPEDANCE WAS OBSERVED. THE MAX RV IMPEDANCE MEASUREMENT VARIED OVER THE DURATION OF THE RECORD WITH A RANGE FROM 696 - 1392 OHMS.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND VARYING RESISTANCE/IMPEDANCE WAS OBSERVED. THE MAX RV IMPEDANCE MEASUREMENT VARIED OVER THE DURATION OF THE RECORD WITH A RANGE FROM 696 - 1392 OHMS. (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. DEVICE MEETS EXPECTED LONGEVITY.
IT WAS REPORTED THAT THE RV PACING IMPEDANCE WAS VARYING FROM 600 OHMS UP TO 1300 OHMS ("SPIKING") THROUGHOUT THE LONG TERM TREND. THE COMPANY TECHNICAL REPRESENTATIVE SUGGESTED THE DATA ARE CONSISTENT WITH EITHER LEAD FRACTURE OR A CONNECTOR ISSUE. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154ATG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other | 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |