SYNERGY VERSITREL
Report
- Report Number
- 3004209178-2014-08326
- Event Type
- Injury
- Date Received
- May 1, 2014
- Report Date
- April 12, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7 48910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-33, LOT# V266474, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33, LOT# V260716, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4). DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW FOR URINARY CONTROL, PMA # P970004.
(B)(4).
ADDITIONAL INFORMATION RECEIVED NOTED THAT APPOINTMENT DATE MAY 6 WAS NOTED. BY THE STATEMENT: THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE, IT WAS NOTED "MAYBE" WITH A QUESTION MARK.
IT WAS REPORTED THAT EVER SINCE THE PATIENT RECEIVED THE MES (ABOUT 3-4 MONTHS AFTER IMPLANT) AS BLADDER DROPPED, SHE HAD BEEN HAVING CONSTANT INFECTIONS. THE PATIENT NOTED SHE SHOULDN'T HAVE TO WEAR PADS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT NONE OF THIS WAS RELATED TO THE DEVICE AND NO FOLLOW-UP WAS NEEDED BY THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263229 | SYNERGY VERSITREL | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427V-NP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |