FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 1874572
·
Received October 19, 2010
Report
- Report Number
- 6000144-2010-05385
- Event Type
- Injury
- Date Received
- October 19, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
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.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT HER ATRIAL LEAD HAD "PUNCTURED THE ATRIUM". THE LEAD WAS REMOVED AND REPLACED. THE PATIENT REPORTED HAVING DIFFICULTY BREATHING; SHE WAS TOLD SHE HAD PERICARDITIS. ONE MONTH LATER, SHE RETURNED TO THE HOSPITAL AND "IT HAD FILLED WITH BLOOD AGAIN". THE SYSTEM 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 |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | 5054 IMPLANTABLE PACING LEAD |