SPRINT
Report
- Report Number
- 2182208-2012-03343
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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) - THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 15:00:06 AND (B)(4) 2012 15:00:06. WEEKLY HV- LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX SVC DEFIB IMPEDANCE = 55 TO 254 OHMS PEAK BETWEEN (B)(4) 2012.
IT WAS REPORTED THAT THE REMOTE TRANSMISSION SHOWED AN ALERT WAS TRIGGERED FOR HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) PORTION OF THE LEAD. FRACTURE WAS SUSPECTED. FURTHER TESTING WILL BE PERFORMED REGARDING THE LEAD, AND THE LEAD REMAINS 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 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6937 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |