FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 2123460
·
Received June 14, 2011
Report
- Report Number
- 2649622-2011-07971
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- March 1, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE LEAD MOVED FROM THE APICAL POSITION. THE LEAD WAS REMOVED AND THE PHYSICIAN DECIDED TO USE AN ACTIVE FIXATION LEAD. 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 SENSE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4074 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |