PRIMEADVANCED
Report
- Report Number
- 9614453-2014-02583
- Event Type
- Injury
- Date Received
- November 4, 2014
- Report Date
- October 6, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- 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
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37081-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37081-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
IT WAS REPORTED THE PATIENT¿S EXTENSIONS WERE REPLACED BECAUSE THEY WERE ¿BROKEN.¿ IMPEDANCE TESTING WAS PERFORMED AND FOUND HIGH IMPEDANCES OF ¿>10000¿ OHMS THAT WERE ATTRIBUTED TO THE PATIENT¿S EXTENSIONS. THE PATIENT REPORTEDLY EXPERIENCED A LACK OF THERAPY DUE TO THE EVENT. THERE WERE NO PATIENT FALLS REPORTED. THE REPORTING MANUFACTURER REPRESENTATIVE ¿GUESSED THAT PROBABLY THE PROBLEM WAS (DUE TO) MOVEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS).¿ FOLLOWING THE REPLACEMENT OF THE PATIENT¿S EXTENSIONS, THE PATIENT WAS NOTABLY ¿OK.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH EXTENSIONS HAD IMPEDANCE GREATER THAN 10,000 OHMS AND BOTH WERE BROKEN. BOTH OF THE EXTENSIONS WERE EXPLANTED AND REPLACED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE EXTENSION WERE BROKEN BECAUSE THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED ON THE IMPLANT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708013 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |