FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL TR
MDR report key: 4131488
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-16106
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 DURING THRESHOLD TESTING NOISE WAS SEEN ON BOTH THE COMPETITOR RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CHANNELS WITH TELEMETRY INTERFERENCE THAT RESULTED IN GREATER THAN TWO SECONDS OF PACING INHIBITION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT THERE WAS LIKELY ELECTROMAGNETIC INTERFERENCE (EMI) OCCURRING AS THE NOISE WAS ABLE TO BE RECREATED WHEN THE PATIENT CHANGED POSITIONS OR THE WAND WAS MOVED. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611853 | CONTAK RENEWAL TR | IMPLANTABLE CHF GENERATOR | NKE | GUIDANT CRM CLONMEL IRELAND | H125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | 4518| 5068| H125| KSR701 |