FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2203572
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11884
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD IN/ON THE HELIX MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELL A FEW WEEKS AGO AND STARTED EXPERIENCING DIAPHRAGMATIC STIMULATION WITH RIGHT VENTRICULAR PACING. THE LEAD TESTED WITHIN NORMAL LIMITS; HOWEVER, THE PHYSICIAN CHOSE TO EXPLANT THE LEAD AND PLACE A NEW LEAD IN A DIFFERENT POSITION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | ADDR01 IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD |