FDA Adverse Event
Injury
Summary report: N
SCREW-IN
MDR report key: 1921403
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12507
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K896313
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POSSIBLE INNER INSULATION BREACH ON THE RA LEAD. LOW IMPEDANCE IN BOTH THE UNIPOLAR AND BIPOLAR WERE ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4058M | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention | SDR303 IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |