RESTORE ULTRA
Report
- Report Number
- 3004209178-2012-03269
- Event Type
- Injury
- Date Received
- May 14, 2012
- Date of Event
- April 26, 2012
- Report Date
- April 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 8590-9 LOT# N274336, IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP ACCESSORY PRODUCT ID 3777-75 LOT# SERIAL# (B)(4). IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N203697, IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP ACCESSORY. (B)(4).
PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD.
(B)(4)
IT WAS REPORTED THERE WAS AN IMPEDANCE ISSUE WITH A READING >40000 OHMS ON ELECTRODES 0, 4 AND SOME COMBINATION WITH ELECTRODES 6,7. THE HIGH VALUE RANGED FROM 15,000-35,000 OHMS ON MAJORITY OF THE OTHER CONTACTS. THE ONLY GOOD COMBINATIONS WERE 1/3. 1/5, 3/5. IT WAS BELIEVED THAT 3/5 WERE GOING TO BE TOO FAR DOWN THE LEAD AS THE PATIENT WAS USING 0,1,2 AS ACTIVE ELECTRODES. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT AND ACUTE PAIN AT THE LEAD SITE WHICH WAS PRESENT WHETHER STIM WAS ON OR OFF. THE PATIENT'S LOCATION WAS THE CLINIC. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. THE PATIENT'S STATUS WAS FAIR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE HIGH IMPEDANCES RESOLVED. IT WAS UNKNOWN WHAT DIAGNOSTIC TESTING WAS PERFORMED BUT IT WAS REPORTED THE "SYSTEM LOOKED INTACT." THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. AS OF THE DATE OF THIS REPORT PATIENT OUTCOME WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED, THE STIMULATOR "QUIT WORKING." IT WAS STATED THE LEAD WAS BROKEN. IT WAS INDICATED, THE PATIENT HAD SURGERY ON (B)(6) 2012 TO CORRECT THE LEAD. IT WAS ADDITIONALLY NOTED, THE PATIENT HAD A REPLACEMENT ON THE SAME DATE WITH A "NEW DEVICE." IT WAS UNCLEAR IF ONLY THE LEAD WAS REPLACED, OR BOTH THE LEAD AND IMPLANTABLE NEUROSTIMULATOR. IT WAS ALSO NOTED THAT THE REPORTER WAS TOLD THE "INS WAS MOVED." PER MANUFACTURER DEVICE REGISTRATION, ONLY A LEAD WAS REPLACED ON THAT DATE. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. REFER TO MANUFACTURER REPORT #3004209178-2013-01088. THE REFERENCED REPORT CONTAINS INFORMATION REGARDING ISSUES THAT FOLLOWED THE LEAD REPLACEMENT NOTED IN THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT "THE PATIENT WAS SUPPOSED TO CONTACT A PHYSICIAN IF HE WANTED A REVISION". IT WAS UNCERTAIN IF THE PATIENT UNDERWENT A REVISION.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS NOT WORKING AND ALL OF THE CONTACTS HAD HIGH IMPEDANCES. A LEAD FRACTURE WAS SUSPECTED. 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 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |