RESTORE
Report
- Report Number
- 3004209178-2013-11656
- Event Type
- Injury
- Date Received
- July 12, 2013
- Report Date
- June 24, 2013
- 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
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 377760, LOT# V017623, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
FOLLOW UP INFORMATION REPORTED THAT THE LEAD REPLACEMENT DID RESOLVE THE ISSUE AND THE ROOT CAUSE OF THE PROBLEM WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THE PATIENT¿S LEAD WAS REPLACED DUE TO ¿HIGH IMPEDANCES.¿ IT WAS NOTED THE PATIENT WAS ALIVE WITH ¿NO INJURY/NO ADVE RSE EVENT.¿ IT WAS FURTHER NOTED THAT ¿THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.IT WAS STATED THE LEAD WOULD NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321561 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |