FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2202912
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11568
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 ATRIUM (RA) LEAD HAD A RA LEAD PERFORMANCE ISSUE DUE TO AN APPARENT CLAVICLE CRUSH WHICH WAS VISIBLE FROM X-RAY. THEREFORE THE RA LEAD WAS CAPPED AND NOT REPLACED DUE TO PATIENT GOING FROM A DUAL TO SINGLE CHAMBER DEVICE. 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 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4068 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| R | 4092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |