FDA Adverse Event
Injury
Summary report: N
CAPSURE VDD-2
MDR report key: 2203270
·
Received August 11, 2011
Report
- Report Number
- 6000023-2011-00017
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC, B.V.
- Product Code
- DTB
- PMA / PMN Number
- P890003/S50
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
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 THERE WAS INTERMITTENT SENSING ON THE ATRIAL PORTION OF THE LEAD. THE ATRIAL PORTION OF THE LEAD WAS CAPPED, A NEW ATRIAL LEAD WAS IMPLANTED, AND THE RIGHT VENTRICULAR PORTION 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 VDD-2 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, B.V. | 5038 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |