RESTORE ULTRA
Report
- Report Number
- 3004209178-2012-08826
- Event Type
- Injury
- Date Received
- October 3, 2012
- Report Date
- June 1, 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
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID 3778-60, LOT # UNKNOWN, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(4) 2012, PRODUCT TYPE LEAD, PRODUCT ID 3778-60, LOT # UNKNOWN, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 3550-39, LOT # UNKNOWN, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS OF LEAD #1, LOT # UNKNOWN, FOUND NO ANOMALY. ANALYSIS OF LEAD #2, LOT # UNKNOWN, FOUND THE OUTER INSULATION OF THE LEAD BODY WAS MELTED (SUSPECTED CAUTERY ARTIFACT) WITH NO SIGNIFICANT ANOMALY. ANALYSIS OF THE TITAN ANCHOR FOUND CUT SILICONE WITH NO SIGNIFICANT ANOMALY.
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE STIMULATION IN HIS BACK. THE PATIENT WAS ALSO "FEELING PRESSURE." A POSSIBLE BREAKAGE WAS MENTIONED. THE LEADS WERE REPLACED, AND THE PATIENT RECOVERED WITHOUT SEQUELAE.
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 | Required Intervention |