FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 3992163
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02413
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 21, 2014
- Report Date
- June 30, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE NEGATIVE POLARITY OF THE CABLE WAS NOT CONDUCTING. AS A RESULT THE CABLE WAS REPLACED AND A NEW CABLE WAS SENT TO THE CUSTOMER.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHODE OF THE PATIENT CABLE WAS NOT CONDUCTING. THE PATIENT CABLE WAS RETURNED FOR SERVICING. IT IS UNKN OWN IF THERE WAS PATIENT INVOLVEMENT WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470634 | NA | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC, INC. | 5433V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5318 EXTERNAL PULSE GENERATOR |