FDA Adverse Event
Injury
Summary report: N
ATTAIN OVER THE WIRE LEAD
MDR report key: 3991910
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-10095
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- December 20, 2013
- Report Date
- June 26, 2024
- Manufacturer
- MPRI
- Product Code
- LWP
- UDI-DI
- 00885074200736
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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: 8042B, BIV IPG IMPLANTED: (B)(6) 2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD. THE LEAD PROGRAMMING WAS ADJUSTED AND THE LV 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 |
|---|---|---|---|---|---|---|---|
| 468434 | ATTAIN OVER THE WIRE LEAD | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | MPRI | 419388 | 00885074200736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Hospitalization| R | 407658, LEAD| 407658, LEAD |