FDA Adverse Event
Injury
Summary report: N
ATTAIN
MDR report key: 3152801
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05699
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 26, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 ID D334TRG, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013; PRODUCT ID 5076, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013; PRODUCT ID 694765, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254725 | ATTAIN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 2187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |