FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2113748
·
Received June 2, 2011
Report
- Report Number
- 9614453-2011-03909
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 10, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTABLE NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL SUSPECTED EARLY BATTERY DEPLETION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS EXPLANTED, BUT NOT REPLACED. THE PT WAS NOT INJURED AND WAS OKAY FOLLOWING EXPLANT. A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC EUROPE SARL | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |