FDA Adverse Event
Malfunction
Summary report: N
S-ICD SYSTEM
MDR report key: 6615102
·
Received June 6, 2017
Report
- Report Number
- 2124215-2017-08953
- Event Type
- Malfunction
- Date Received
- June 6, 2017
- Date of Event
- May 9, 2017
- Report Date
- May 18, 2017
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- UDI-DI
- 00802526584404
- PMA / PMN Number
- P110042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS FIELD CLINICAL MANAGER (FCM) CONTACTED BOSTON SCIENTIFIC¿S TECHNICAL SERVICES ON (B)(6) 2017. THE FCM REPORTED DIFFICULTIES INTERROGATING THIS DEVICE. THE FCM WAS ABLE TO ESTABLISH TELEMETRY WHEN THE DEVICE WAS TAKEN OUT OF THE BOX. TS COMMENTED THAT THE PHYSICIAN COULD CONSIDER TURNING THE PROGRAMMER OFF EACH TIME TO RESET THE ABILITY TO FIND THE BEST FREQUENCY. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NO FURTHER INTERROGATION ISSUES WERE ENCOUNTERED. DEVICE-BASED TESTING WAS SUCCESSFUL AND THE DEVICE REMAINS IN-SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396016 | S-ICD SYSTEM | LWS | GUIDANT CRM CLONMEL IRELAND | A219 | 00802526584404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 220 MO | 3401| A219 |