FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL TR
MDR report key: 3905733
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-11200
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 16, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- PMA / PMN Number
- P030005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- 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 LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS IN ALL VECTORS EXCEPT LV TIP TO CAN AND EXTENDED BIPOLAR IN LV TIP TO RIGHT VENTRICULAR (RV) LEAD, WHICH DISPLAYED MEASUREMENTS WITHIN ACCEPTABLE LIMITS. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED RECOMMENDATIONS. THE DEVICE WAS REPROGRAMMED TO THE LV TIP TO RV CONFIGURATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385019 | CONTAK RENEWAL TR | IMPLANTABLE CHF GENERATOR | NKE | GUIDANT CRM CLONMEL IRELAND | H120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | H120| 4543| 4471| 4470 |