FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3153612
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06126
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCTS: 6947 IMPLANTABLE DEFIB LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT, THE ATRIAL LEAD WAS CUT. UPON TESTING, THE IMPEDANCE WAS LESS THAN 200 OHMS AND OVERSENSING WAS SEEN. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254273 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | D154AWG IMPLANTABLE DEFIBRILLATOR |