FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2040769
·
Received March 22, 2011
Report
- Report Number
- 3007566237-2011-02201
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 8, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION AT THE LEAD-EXTENSION CONNECTION SITE. THE IMPEDANCES WERE MEASURED AND RESULTS WERE NORMAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC NEUROMODULATION | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |