ATTAIN OTW
Report
- Report Number
- 2649622-2010-01885
- Event Type
- Death
- Date Received
- April 21, 2010
- Date of Event
- January 20, 2010
- 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
- GA, 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.
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 DEVICE WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED NORMAL DEPLETION. ANALYSIS OF THE LEAD IS IN PROGRESS AND RESULTS WILL BE FORWARDED WHEN ANALYSIS IS COMPLETED.
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 DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NORMAL DEPLETION. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), OUTER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY MELTED, OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, EXPOSED DEFIB COIL WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.
IT WAS REPORTED DEVICE WAS AT END OF LIFE WITH ELEVATED LV(LEFT VENTRICULAR) CAPTURE THRESHOLDS. DURING REPLACEMENT SURGERY, IT WAS NOTED HEART SHADOW NO LONGER MOVING. COMPRESSIONS STARTED AND STANDARD ACLS (ADVANCED CARDIAC LIFE SUPPORT) PROTOCOLS IMPLEMENTED. PULSES PRESENT WITH COMPRESSIONS AND ABSENT WITHOUT COMPRESSIONS. ECHOCARDIOGRAM CONFIRMED ABSENCE OF PERICARDIAL FLUID, FLUOROSCOPY CONFIRMED ABSENCE OF ANY CARDIAC ACTIVITY AND ABSENCE OF A LARGE PNEUMOTHORAX. THE PATIENT'S DEATH WAS CLASSIFIED AS PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST DURING DEVICE CHANGEOUT AND CHRONIC RENAL FAILURE. HOSPITAL RECORDS REPORTED SURGERY DONE WITHOUT ANY EVIDENCE OF COMPLICATION, VENTRICULAR FIBRILLATION NOT INDUCED DURING CASE, AND "IT MAY REPRESENT END-STAGE HEART FAILURE." FOLLOW UP REPORTED THE STUDY SITE HAS INDICATED "THE DEATH WAS A RESULT OF THE IMPLANT PROCEDURE AND A RESULT OF DEVICE OR LEAD SYSTEM PERFORMANCE NOT TO SPECIFICATION."
IT WAS REPORTED DEVICE WAS AT END OF LIFE WITH ELEVATED LV(LEFT VENTRICULAR) CAPTURE THRESHOLDS. DURING REPLACEMENT SURGERY, IT WAS NOTED HEART SHADOW NO LONGER MOVING. COMPRESSIONS STARTED AND STANDARD ACLS (ADVANCED CARDIAC LIFE SUPPORT) PROTOCOLS IMPLEMENTED. PULSES PRESENT WITH COMPRESSIONS AND ABSENT WITHOUT COMPRESSIONS. ECHOCARDIOGRAM CONFIRMED ABSENCE OF PERICARDIAL FLUID, FLUOROSCOPY CONFIRMED ABSENCE OF ANY CARDIAC ACTIVITY AND ABSENCE OF A LARGE PNEUMOTHORAX. THE PATIENT'S DEATH WAS CLASSIFIED AS PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST DURING DEVICE CHANGEOUT AND CHRONIC RENAL FAILURE. HOSPITAL RECORDS REPORTED SURGERY DONE WITHOUT ANY EVIDENCE OF COMPLICATION, VENTRICULAR FIBRILLATION NOT INDUCED DURING CASE, AND "IT MAY REPRESENT END-STAGE HEART FAILURE." FOLLOW UP REPORTED THE STUDY SITE HAS INDICATED "THE DEATH WAS A RESULT OF THE IMPLANT PROCEDURE AND A RESULT OF DEVICE OR LEAD SYSTEM PERFORMANCE NOT TO SPECIFICATION."
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 | 41 YR | Death| O | 6947 IMPLANTABLE TACHY LEAD| (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |