FDA Adverse Event
Injury
Summary report: N
SELECT SECURE
MDR report key: 1874600
·
Received October 19, 2010
Report
- Report Number
- 2649622-2010-11461
- Event Type
- Injury
- Date Received
- October 19, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 4092 LEAD EXPERIENCED HIGH THRESHOLDS AND THE PATIENT REPORTED FEELING DIZZY. THE LEAD WAS CAPPED. DURING THE ATTEMPTED IMPLANT OF THE REPLACEMENT LEAD, THE 3830 LEAD COULD NOT GET DECENT THRESHOLDS. A DIFFERENT REPLACEMENT LEAD WAS IMPLANTED. 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 | SELECT SECURE | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 3830 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | SDR303 IMPLANTABLE PULSE GENERATOR| 4592 IMPLANTABLE PACING LEAD |