FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 3071800
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05283
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 21, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2011 (B)(6); 4076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY DEPLETED EARLIER THAN EXPECTED. THE ICD WAS EXPLANTED AND REPLACED. ALSO REPORTED WAS THAT THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED TO HAVE BECOME DISLODGED AND HAD HIGH THRESHOLD. THE LV LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172218 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | 6944 IMPLANTABLE TACHY LEAD |