FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 3863478
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06760
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 11, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- 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. PRODUCTS: ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED 2007 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE P-WAVE SENSING ON THE RIGHT ATRIAL (RA) LEAD WAS VERY LOW AT THE CURRENT DEVICE SETTINGS. THE PHYSICIAN WAS NOT CONCERNED WITH THE SMALL P-WAVES AND THE LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 337652 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5068-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00095 YR | 5054-58 IMPLANTABLE PACING LEAD |