FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2193280
·
Received July 13, 2011
Report
- Report Number
- 3004209178-2011-05370
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 1, 2011
- Report Date
- December 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION AND THERE WAS A LOSS OF THERAPEUTIC EFFECT (RETURN OF HEADACHES). IT WAS REPORTED THAT THERE WAS A "CALL YOUR DOCTOR" EOS MESSAGE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS REPORT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT #V469510006 .| PROGRAMMER: MODEL 37743, LOT #NKE164856N.| LEAD: MODEL 39286-65, LOT #V469510006| PROGRAMMER: MODEL 37743, LOT #NKE164856N| EXPLANTED:| IMPLANTED: |