FDA Adverse Event
Injury
Summary report: N
CAPSURE Z
MDR report key: 1926359
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-14304
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S33
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 THE RIGHT ATRIAL LEAD WAS "UNDERPERFORMING", HAD INCREASING PACING THRESHOLD AND WAS CAPPED. THE LEAD MAY HAVE BEEN COMPROMISED DURING THE ABLATION PROCEDURES FOR ATRIAL FIBRILLATION. A NEW RIGHT ATRIAL LEAD WAS IMPLANTED. 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 Z | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5534 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | 5034 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |