FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1803316
·
Received August 17, 2010
Report
- Report Number
- 2649622-2010-08799
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Date of Event
- March 16, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED WITH SYNCOPE AT THE HOSPITAL EMERGENCY ROOM AND THE LEAD HAD RIGHT VENTRICULAR OVERSENSING. REPROGRAMMING WAS DONE TO SENSE AT THE TIP TO COIL. THE LEAD EXTRACTION WAS PLANNED FOR A LATER DATE AND TWO WEEKS LATER, THE LEAD HAD FRACTURED. WHILE THE PHYSICIAN ATTEMPTED TO EXTRACT THIS LEAD, THE ATRIAL LEAD BECAME UNUSABLE. THE LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R | 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |