FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE DEVICE
MDR report key: 8523719
·
Received April 17, 2019
Report
- Report Number
- 2124215-2019-06863
- Event Type
- Malfunction
- Date Received
- April 17, 2019
- Date of Event
- March 12, 2019
- Report Date
- April 17, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P960040/S155
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DEVICE REPLACEMENT WAS RECOMMENDED. NAE; ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317366 | IMPLANTABLE DEVICE | LWP | BOSTON SCIENTIFIC CORPORATION | E110 | 164121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |