FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2041451
·
Received March 24, 2011
Report
- Report Number
- 3004209178-2011-02254
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 STIMULATOR LOCATION, CHEST, AND DOWN THE PT'S LEGS. THE PT EXPERIENCED A "TASED" FEELING. THE PT HAD THE STIMULATOR TURNED OFF BECAUSE OF THE SHOCKING. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | EXPLANTED:| LEAD: MODEL 3777, LOT # V521383009| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE155155N| EXPLANTED:| LEAD: MODEL 3777, LOT # V521383008 |