FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1864342
·
Received October 7, 2010
Report
- Report Number
- 3004209178-2010-07697
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- February 1, 2010
- Report Date
- September 9, 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
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THEY FELT SHOCKING IN A BAND AROUND THE CHEST AND BELIEVED IT WAS AROUND THE EXTENSION LOCATION (T5/T6). WHEN THE UNIT IS OFF, THE PATIENT DID NOT FEEL THE SHOCK. THERE WAS NO KNOWN INCIDENT RELATED TO THIS COMPLAINT. THIS STARTED IN (B)(6) 2010. PATIENT DID HAVE THE LEADS REVISED DUE TO "ISSUES." THIS DEVICE WAS IN THE CERVICAL AREA. PATIENT ALSO HAD A SPINAL CORD STIMULATION (SCS) DEVICE FOR THE DORSAL AREA. A MEETING WITH THE COMPANY REPRESENTATIVE WAS BEING SCHEDULED. ADDITIONAL INFORMATION 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 ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE140259N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132557N| EXPLANTED:| IMPLANTED:| EXTENSION: MDOEL 37081, LOT# NJB070011V| EXPLANTED:| LEAD: MODEL 3777, LOT# V345323014| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V357770036| EXTENSION: MODEL 37081, LOT# NJB070012V| IMPLANTED: |