UNKNOWN EXTERNAL STIMULATOR
Report
- Report Number
- 3007566237-2014-01642
- Event Type
- Injury
- Date Received
- June 13, 2014
- Report Date
- October 4, 2017
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3058, SERIAL (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3058, SERIAL (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE PATIENT HAD AN INFECTION. THE EVENT WAS ASSESSED AS NON-SERIOUS AND RELATED TO THE TEST IMPLANT PROCEDURE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE EVENT WAS NOTED AS RECOVERED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION WAS REPORTED AS RECOVERED ON 2014-(B)(6).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014 TO EXPLANT THE NEUROMODULATOR. THE EVENT RESOLVED ON (B)(6) 2014. THE EVENT WAS CONSIDERED SERIOUS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ACTIONS TAKEN WERE EXPLANT OF THE NEUROMODULATOR AND LEAD ON (B)(6) 2014 AND ANTIBIOTIC MEDICATION. THE EVENT RESOLVED ON (B)(6) 2014. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS ASSESSED AS RELATED TO DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN IMPLANT SITE INFECTION ON (B)(6) 2014 DURING A TEST. THE PRINCIPAL INVESTIGATOR ASSESSED AS SERIOUS, RELATED TO PROCEDURE, NOT RELATED TO THE DEVICE AND THE SPONSOR ASSESSED THE EVENT AS SERIOUS, RELATED TO PROCEDURE, AND RELATED TO THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349631 | UNKNOWN EXTERNAL STIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R |