FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2203613
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01537
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- March 29, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED INCREASING RIGHT VENTRICULAR (RV) THRESHOLD FOLLOWING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE DEVICE WAS REPROGRAMMED, HOWEVER PATIENT CONTINUED TO HAVE INTERMITTENT LOSS OF CAPTURE (LOC). THEREFORE THE IPG WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE RV LEAD REMAINS IN USE. 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 | REVO MRI SURESCAN | IMPLANTABLE PULSE GENERATOR | LWP | MEDTRONIC S.A. | RVDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACING LEAD |