FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 3864874
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07466
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 3, 2014
- Report Date
- March 5, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6945-65 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED WHILE THE PATIENT WAS CLEANING THEIR REFRIGERATOR. NON-PHYSIOLOGIC OVERSENSING WAS OBSERVED ON THE STORED EPISODES ON BOTH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. THE RV AND RA LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337662 | CAPSUREFIX | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6940-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | D314DRG ICD |