FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2100310
·
Received May 16, 2011
Report
- Report Number
- 3004209178-2011-03529
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Report Date
- April 26, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION (DESCRIBED AS "ELECTROCUTED") AND WAS TAKEN TO THE EMERGENCY ROOM. SHE WAS APPREHENSIVE TO TURN UP OR ADJUST THE STIMULATION AFTER THIS EPISODE. ADDITIONAL INFORMATION WAS REQUESTED.
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 | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU014631V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# LB2112| PROGRAMMER: MODEL 7435, LOT# NFT033342P| EXTENSION: MODEL 7489, LOT# NHU014632V| EXPLANTED: |