INTERSTIM
Report
- Report Number
- 2182207-2024-03370
- Event Type
- Injury
- Date Received
- August 2, 2024
- Date of Event
- April 14, 2024
- Report Date
- August 2, 2024
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B5: UPDATED TO CAPTURE ONLY REPORTABLE EVENT. D.2. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; SEE B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S). THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. BESENDORFOR, M., KNORR, C., KIRCHGATTER, A., MULLER., H., WOLFERTSTETTER, P.R., MATZEL, K. ET AL. (2024). SACRAL NEUROMODULATION IN CHILDREN AND ADOLESCENTS WITH DEFECATION DISORDERS. NEUROGASTROENTEROL MOTIL. 2024;36(6):E14808. DOI:10.1111/NMO.14808. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
LITERATURE WAS REVIEWED REGARDING SACRAL NEUROMODULATION IN CHILDREN AND ADOLESCENTS WITH DEFECATION DISORDERS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: INTERSTIM¿ II AND MICRO SNS SYSTEM. AMONG PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: 1. IT WAS REPORTED ONE PATIENT AGE 5, HAD AN ELECTRODE BREAKAGE OCCURRED WHICH LED TO A REVISIONAL SURGERY. STIMULATION WAS TERMINATED IMMEDIATELY AFTER DIAGNOSIS AND DID NOT CAUSE ABNORMAL SENSATION OR PAIN. THE PATIENT'S SAFETY WAS NOT COMPROMISED AND THE SURGERY FOR ELECTRODE EXCHANGE WAS WITHOUT COMPLICATIONS.
LITERATURE WAS REVIEWED REGARDING SACRAL NEUROMODULATION IN CHILDREN AND ADOLESCENTS WITH DEFECATION DISORDERS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: INTERSTIM¿ II AND MICRO SNS SYSTEM. AMONG PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: 1. IT WAS REPORTED ONE PATIENT AGE 5, HAD AN ELECTRODE BREAKAGE OCCURRED WHICH LED TO A REVISIONAL SURGERY. STIMULATION WAS TERMINATED IMMEDIATELY AFTER DIAGNOSIS AND DID NOT CAUSE ABNORMAL SENSATION OR PAIN. THE PATIENT'S SAFETY WAS NOT COMPROMISED AND THE SURGERY FOR ELECTRODE EXCHANGE WAS WITHOUT COMPLICATIONS. 2. IT WAS REPORTED THAT THERE WAS AN INCREASE OF URINARY INCONTINENCE IN TWO PATIENTS. BOTH WHO SUFFERED FROM URINARY DYSFUNCTION PRIOR TO TREATMENT. AFTER REDUCTION OF STIMULATION INTENSITY, SYMPTOMS RESOLVED. 3. IT WAS REPORTED THAT THREE PATIENT¿S HAD A RELAPSE OF SYMPTOMS. ONE PATIENT DURING THE FIRST 6 MONTHS OF STIMULATION TREATMENT. AND THEN IN TWO PATIENTS AFTER 10¿12 MONTHS OF TREATMENT, RESULTING IN FREEDOM OF SYMPTOMS AT 1- YEAR FOLLOW UP. AN INCREASE OF STIMULATION INTENSITY AND RESUMPTION OF MEDICATION WITH PEG AGAIN LED TO SYMPTOM CONTROL IN THESE THREE CASES OF RELAPSE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370503 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Female | Required Intervention | "SEE H11...." |