SCREW-IN
Report
- Report Number
- 2649622-2010-11980
- Event Type
- Injury
- Date Received
- October 27, 2010
- 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
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTED DEVICE CONCLUSION: EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED; PARTIAL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE DISTAL CONDUCTOR WAS STRETCHED. THE OUTER INSULATION HAD COSMETIC DEPRESSIONS AND A WHITE SUBSTANCE WAS OBSERVED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED; PARTIAL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE DISTAL CONDUCTOR WAS STRETCHED. THE OUTER INSULATION HAD COSMETIC DEPRESSIONS AND A WHITE SUBSTANCE WAS OBSERVED.
IT WAS REPORTED THAT THE LEAD HAD HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED 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 | ASKU | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Hospitalization| R | E1DR01 IMPLANTABLE PULSE GENERATOR| 5072 IMPLANTABLE PACING LEAD| 5072 IMPLANTABLE PACING LEAD| E1DR01 IMPLANTABLE PULSE GENERATOR |