ASKU
Report
- Report Number
- 2649622-2010-11600
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- June 7, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; PROXIMAL SEGMENT OF THE LEAD WAS RETURNED FOR ANALYSIS.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; PROXIMAL SEGMENT OF THE LEAD WAS RETURNED FOR ANALYSIS. ANALYSIS ALSO NOTED OUTER INSULATION COSMETIC DEPRESSION.
IT WAS REPORTED THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THERE WAS A PROGRESSIVE THRESHOLD RISE ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE LEAD HAD DISLODGED. 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 | ASKU | ASKU | LWS | MEDTRONIC PUERTO RICO, INC. | ASKU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD |