ATTAIN OTW
Report
- Report Number
- 2649622-2011-10449
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S003
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN "PROGRAMMED OFF" PREVIOUSLY FOR HIGH IMPEDANCE AND NO CAPTURE. THE PHYSICIAN HAD NOTED THAT "AT SOME POINT THE PATIENT [HAD] INSERTED A KNIFE INTO [THE] DEVICE POCKET" WHICH COULD HAVE "POTENTIALLY DAMAGED THE LV" LEAD. IT WAS FURTHER REPORTED THAT THE LV LEAD EXPERIENCED AN APPARENT FRACTURE AND HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN "PROGRAMMED OFF" PREVIOUSLY FOR HIGH IMPEDANCE AND NO CAPTURE. THE PHYSICIAN HAD NOTED THAT "AT SOME POINT THE PATIENT [HAD] INSERTED A KNIFE INTO [THE] DEVICE POCKET" WHICH COULD HAVE "POTENTIALLY DAMAGED THE LV" LEAD. IT WAS FURTHER REPORTED THAT THE LV LEAD EXPERIENCED AN APPARENT FRACTURE AND HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN 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. | 4193 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |