FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 3152187
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05530
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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. PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NORMAL BATTERY DEPLETION. (B)(4). CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2009 (B)(6); 694758 IMPLANTABLE TACHY LEAD IMPLANTED: 2009 (B)(6); 4592-53 IMPLANTABLE PACING LEAD IMPLANTED: 2009 (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED AN INFECTION OCCURRED. THE LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252957 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R |