FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2130403
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10159
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THAT DURING AN OFFICE CHECK, NOISE OVERSENSING WAS NOTED ON BOTH THE ATRIAL AND VENTRICULAR LEADS. IT WAS FURTHER REPORTED THAT THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN OFFICE CHECK, NOISE OVERSENSING WAS NOTED ON BOTH THE ATRIAL AND VENTRICULAR LEADS. THE LEADS 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 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR |