FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 2596078
·
Received June 1, 2012
Report
- Report Number
- 3004209178-2012-03936
- Event Type
- Injury
- Date Received
- June 1, 2012
- Report Date
- May 4, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3998 LOT# LB2124, IMPLANTED: (B)(6) 2003; PRODUCT TYP LEAD, PRODUCT ID 37742, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008; PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3708260, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYP EXTENSION, PRODUCT ID 3550-29, LOT# N142181, IMPLANTED: (B)(4), 2008; PRODUCT TYP ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD "SNAPPED" WHILE THE PATIENT WAS GARDENING. THE LEAD WAS REPLACED AND AN ADDITIONAL LEAD WAS ALSO PLACED. THE PHYSICIAN LEFT THE BROKEN LEAD INSIDE THE PATIENT AND CAPPED IT. THE PATIENT WAS "VERY HAPPY" AFTER THE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |