FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2952696
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00677
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 5, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
5076 IMPLANTABLE PACING LEAD, 2012 (B)(6), 6949 IMPLANTABLE TACHY LEAD, 2005 (B)(6), (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT A NEW SYSTEM WAS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BACTEREMIA. DRAINAGE FROM THE DEVICE SITE, HEMATOMA, FEVER AND POSITIVE (B)(6) BACTEREMIA WERE NOTED. ANTIBIOTICS WERE ADMINISTERED AND THE ENTIRE SYSTEM WAS LATER EXPLANTED AND NOT REPLACED. THE PATIENT WAS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56223 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |