FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 3132480
·
Received May 29, 2013
Report
- Report Number
- 6000032-2013-00139
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- October 9, 2015
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3888-28, LOT# L34679, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: EXTENSION. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTED DEVICE ONLY LASTED 8 MONTHS.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED PREMATURE BATTERY DEPLETION AND THEY THOUGHT THE BATTERY WAS DEFECTIVE, BUT WHEN THEY FOUND OUT SHE WAS RUNNING IT HIGH AND 24 HOURS A DAY IT WAS DUE TO THE PATIENT DRAINING THE BATTERY BECAUSE OF USAGE. INDICATION FOR USE INCLUDED FAILED BACK SURGERY SYNDROME AND ARACHNOIDITIS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235946 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |