FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3153351
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05950
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 4076 IMPLANTABLE PACING LEAD (B)(6) 2007, 0158 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS AN INSULATION BREACH LOCATED AT THE JUNCTION OF THE LEAD BODY AND TERMINAL PIN. THE LEAD WAS REPAIRED BY THE PHYSICIAN AND 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 |
|---|---|---|---|---|---|---|---|
| 255330 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |