FDA Adverse Event
Injury
Summary report: N
SCREW-IN
MDR report key: 2212278
·
Received August 15, 2011
Report
- Report Number
- 2649622-2011-13620
- Event Type
- Injury
- Date Received
- August 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 BOTH LEADS HAD A FRACTURE, NO CAPTURE AT MAXIMUM OUTPUTS, AND INCREASED IMPEDANCES. THE RIGHT ATRIAL LEAD HAD AN INCREASE TO 5000 OHMS SINCE THE INTERROGATION OF THE DEVICE TWO YEARS AGO. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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. | 5071 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |