FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 4160239
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02853
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- May 12, 2014
- Report Date
- July 24, 2014
- 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: DURING ANALYSIS IT WAS DETERMINED THAT THE LOWER CASE WAS BROKEN AND THE INTERCONNECT FLEX WAS FORMED IMPROPERLY. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).
Description of Event or Problem · 1
THE EXTERNAL PULSE GENERATOR WAS RETURNED AS A TRADE-IN/EXCHANGE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638177 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |