FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1890235
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08343
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 28, 2010
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED, THE PT EXPERIENCED ACUTE PAIN AT THE SITE OF HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT, AFTER IMPLANT, THE PT "COULDN'T MOVE HER LEG, AFTER HER HEALTH CARE PROVIDER GAVE HER DEMORAL FOR PAIN CONTROL." THERE WAS CONFLICTING INFO ON WHAT, IF ANY, MEDICATIONS THE PT WAS GIVEN. IT WAS REPORTED, THE PT EXPERIENCED PAIN WHETHER STIMULATION WAS ON OR OFF. 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 ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT#: NKA141091N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT#: NKE140777N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT#: V438026007| STIM ACCESSORY: MODEL 3550-29, LOT#: N253849| EXPLANTED: |