FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2810561
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15760
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S10
- 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. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS VARIABLE IMPEDANCE ON THE HIGH VOLTAGE COIL, RANGING TO HIGH IMPEDANCE. 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 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6932 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R | (B)(4) X2 IMPLANTABLE PAIN STIM LEADS| (B)(4) IMPLANTABLE PAIN STIM GENERATOR| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |