FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 1021861
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00321
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- November 8, 2007
- Report Date
- February 28, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR. THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS COULD BE FOUND THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE ANALYSIS SHOWED NO INDICATIONS OF MFG ERRORS OR MATERIAL DEFECTS. BASED ON THE EXISTING ANALYSIS RESULTS, THE CLINICAL COMPLAINT WAS NOT DUE TO AN INAPPROPRIATE BEHAVIOR OF THE LEAD.
Description of Event or Problem · 1
OUS MDR. ISOLATED DROPS IN THE RIGHT-VENTRICULAR PACING IMPEDANCE OF 400 OHM WERE REPORTED. THE LEAD HAD BEEN IMPLANTED FOR 4 1/2 MONTHS. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |