FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3990962
·
Received August 8, 2014
Report
- Report Number
- 2183613-2014-01012
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- April 28, 2014
- Report Date
- May 23, 2014
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE HAS NO HOOK FOR HANGING. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469711 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |