INTERSTIM II
Report
- Report Number
- 3004209178-2020-06094
- Event Type
- Malfunction
- Date Received
- March 25, 2020
- Report Date
- October 30, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00613994913654
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
CORRECTION H6: PATIENT CODE C26906 WAS ADDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
G5: PMA/510(K) NUMBER UPDATED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER¿S FAMILY MEMBER WHO NOTED THAT THEY WERE FILLING THIS LETTER OUT FOR THE PATIENT. THE FAMILY MEMBER STATED THAT THEY WERE KNOWLEDGEABLE (¿A LITTLE BIT, ANYWAY¿) ABOUT THE DEVICES DUE TO THEIR EXPERIENCE AS AN OPERATING ROOM NURSE. IN RESPONSE TO THE INQUIRY FOR WHAT THE CIRCUMSTANCES WERE THAT LED TO THE DEVICE BEING OFF AND IF A CAUSE WAS DETERMINED THE FAMILY MEMBER REPORTED THAT ¿THIS DEVICE¿ WAS ¿ALWAYS OFF!¿THE FAMILY MEMBER STATED THAT IT WAS SUCH A DISAPPOINTMENT; VERY PROBLEMATIC AND THAT IT TOOK 30 MINUTES AT BEST JUST TO GET THE COMMUNICATOR TO LOCATE THE DEVICE. THE FAMILY MEMBER STATED THAT EACH TIME THEY MANAGED TO GET IT TURNED ON, IT WOULD ONLY LAST 1-2 DAYS. THE FAMILY MEMBER STATED THAT YES, THEY HAD NOTIFIED THE PATIENT¿S HEALTH CARE PHYSICIAN (HCP) THAT THE DEVICE WAS OFF AND NOTED THAT DUE TO COVID-19 THEY HAD NO APPOINTMENT AT THE TIME THAT THEY WROTE THE LETTER. THE FAMILY MEMBER NOTED THERE HAD BEEN A PRIOR APPOINTMENT AT THE HCP OFFICE. THE FAMILY MEMBER REPORTED THAT THEY FELT THAT THERE WAS SOMETHING WRONG WITH THE PATIENT¿S DEVICE. WHILE THEY NOTED THEY DID NOT KNOW THE SPECIFICS OF THE MANUFACTURER COMPANY¿S DEVICE, IT WAS NEVER ON WHEN THEY WOULD TRY TO HELP THE PATIENT FIGURE OUT WHY THE PATIENT CONTINUES WITH IN CONTINENCE. THE FAMILY MEMBER CONTINUED THAT IT WAS VERY PROBLEMATIC AND A LONG, DRAWN OUT PROCESS EACH TIME THEY WOULD HAVE TO COMMUNICATE WITH THE DEVICE. THE FAMILY MEMBER STATED THAT HAVING THE DEVICE IMPLANTED DIDN¿T ALLEVIATE THE PATIENT¿S NEED TO KEEP BUYING INCONTINENCE PADS AND THAT IT WAS VERY DISCOURAGING FOR THE PATIENT. THE FAMILY MEMBER STATED THAT WHEN THEIR OPERATING ROOM PATIENTS ASKED THEM ABOUT THE OUTCOME OF THE DEVICE THAT THEY ARE HONEST AND TELL THEM ABOUT THE PATIENT¿S EXPERIENCE. THE FAMILY MEMBER STATED THAT ¿SOMETHING¿ WAS ¿OVERTLY WRONG WITH THIS DEVICE,¿ AND AT THE APPOINTMENT THEY TOLD THE PATIENT THAT NOTHING WAS WRONG. THE FAMILY MEMBER STATED THAT THEY WERE ONLY TELLING THE MANUFACTURER COMPANY THIS IN THE HOPES THAT SOMEONE COULD HELP THE PATIENT FIX THIS SITUATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO STATED THE DEVICE HELPED CONTROL SYMPTOMS FOR ABOUT A WEEK AFTER IMPLANT, BUT NOT ANYMORE. PATIENT HAD BEEN TO HCP IN (B)(6) 2020 AND (B)(6) 2020 TO ADJUST SETTINGS AND SHE STILL GOING TO THE BATHROOM 4 OR 5 TIMES A NIGHT AND WEARING PADS. PATIENT DECLINED TO TROUBLESHOOT OVER THE PHONE, REQUESTED REP BE CONTACTED AND STATED THE HCP WAS ALSO GOING TO CALL A FIELD MEMBER. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE/GASTROINTESTINAL/ PELVIC FLOOR INDICATIONS FOR USE. IT WAS REPORTED THE CALLER SAID THE DEVICE WAS EFFECTIVE FOR 2 WEEKS, THEN THE PATIENT STARTED HAVING LEAKING. CALLER SAID THE PATIENT WOULD FEEL STIM FOR 2 DAYS THEN THE FEELING STIM WOULD STOP. CALLER SAID EVERY TIME SHE CHECKED THE DEVICE STIM WAS OFF. CALLER SAID SHE TRIED PROGRAMS 1-4 AND INCREASED UP TO 4 AND THE PATIENT WASN'T ABLE TO FEEL STIM. CALLER SAID THE PATIENT USUALLY FEELS STIM AT 2.8 V. DURING CALL CALLER PUT DEVICE ON PROGRAM 5 AND PATIENT WAS ABLE TO FEEL STIM. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341208 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |