FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 4833910
·
Received June 10, 2015
Report
- Report Number
- 2182208-2015-01986
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- February 19, 2015
- Report Date
- April 9, 2015
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Removal / Correction Number
- Z-1661-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS OF THE EPG (EXTERNAL PULSE GENERATOR) FOUND IT FAILED TESTING DUE TO THE INTERCONNECT FLEX BEING OUT OF ELECTRICAL SPECIFICATION. THE BATTERY CONTACTS WERE ALSO CONTAMINATED, THE LOWER CASE BROKEN, UPPER CASE DENTED, AND THE SERIAL NUMBER LABEL TORN. (B)(4).
Description of Event or Problem · 1
THE EPG (EXTERNAL PULSE GENERATOR) WAS RETURNED TO THE MANUFACTURER FOR TRADE-IN. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378058 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |