FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2053511
·
Received April 13, 2011
Report
- Report Number
- 2649622-2011-05915
- Event Type
- Injury
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
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 PATIENT WAS HAVING "ODD SENSATIONS". UPON INTERROGATION, A VENTRICULAR LEAD WARNING WAS NOTED ALONG WITH 39 LOW IMPEDANCE PACES. MULTIPLE VENTRICULAR HIGH RATE EPISODES WERE ALSO NOTED AND LOOKED TO BE NOISE. 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 | CAPSURE SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4024 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |