FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3861307
·
Received June 10, 2014
Report
- Report Number
- 2182208-2014-01766
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 30, 2014
- Report Date
- April 30, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSERTION TOOL DID NOT SECURELY HOLD THE IMPLANTABLE CARDIAC MONITOR IN PLACE. THE ICM WAS OBSERVED TO BE MOVING IN AND OUT OF THE DISTAL ORIFICE OF THE TOOL YET NEVER MORE THAN HALF WAY OUT. THE CONCERN WAS THAT THE ICM COULD HAVE FALLEN OUT. THE TOOL WAS USED TO COMPLETE THE IMPLANT WITH NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340051 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, INC. | MDT-ACCESSORY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |