FDA Adverse Event
Injury
Summary report: N
CAPSURE VDD-2
MDR report key: 2053386
·
Received April 13, 2011
Report
- Report Number
- 2649622-2011-05891
- Event Type
- Injury
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P890003/S50
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL FINDING OF OUTER INSULATION COSMETIC DEPRESSION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, HIGH PACING THRESHOLDS WERE OBSERVED AND X-RAY SHOWED AN APPARENT LEAD FRACTURE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 PUERTO RICO, INC. | 5038 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |