INTERSTIM II
Report
- Report Number
- 3004209178-2013-04539
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 15, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID: 3093-28, LOT# V503604, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT HAD ISSUES 2-3 WEEKS PRIOR TO SEEING HER HEALTHCARE PROFESSIONAL (HCP). IT WAS STATED THAT THE PATIENT HAD URGENCY FREQUENCY, THE BLADDER WASN'T EMPTYING AND THE PATIENT WAS LEAKING. THE PATIENT WAS DIAGNOSED WITH URINARY TRACT INFECTION (UTI) ABOUT ONE MONTH PRIOR TO THE REPORT. THE PATIENT WAS GIVEN LEVAQUIN TO TAKE AND GET RID OF UTI. AFTER THE ANTIBIOTIC TREATMENT, IT WAS STATED THAT "THE UTI WAS CLEAR AS A BELL." WITH REGARDS TO SYMPTOMS WITH HER IMPLANTABLE NEUROSTIMULATOR (INS) THERAPY, IT WAS STATED THAT THE PATIENT STILL WASN'T BACK TO WHERE SHE HAD BEEN BEFORE THE UTI, THE PATIENT WAS GOING MORE OFTEN. IT WAS ALSO STATED THAT THE INS HAD BEEN REPROGRAMMED ONCE BEFORE. IT WAS STATED THAT "THE PATIENT HAD TO WEAR DEPENDS ALL THE TIME SINCE 1.5 MONTHS AGO." THE PATIENT WOULD WEAR A PAD AS A PRECAUTION, SHE HAD ONLY WORE THE PADS UP UNTIL A 1.5 MONTH AGO. WHEN TROUBLESHOOTING WAS ATTEMPTED, IT WAS STATED THAT THE SCREEN WASN'T TURNING ON AND THAT IT WAS TIME TO CHANGE THE PATIENT PROGRAMMER BATTERIES. IT WAS STATED THAT THE INS WAS AT 2.3 V ON PROGRAM 1 "WITH A LIGHTNING BOLT." THE OTHER PROGRAM SETTINGS WERE: PROGRAM 2 AT 3.5 V, PRO GRAM 3 AT 4.5 V, PROGRAM 4 AT 0.0 V. THE STIMULATION WAS BEING ADJUSTED UP SLOWLY WHILE THE PATIENT WAS IN STANDING POSITION AND THE PATIENT FELT SOMETHING AT 3.5 V. IT WAS ALSO STATED THAT THE PATIENT LACKED BASIC UNDERSTANDING OF PATIENT PROGRAMMER USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2013 FOR THE UTI ISSUE. THE PHYSICIAN¿S OFFICE HAD NOT RECEIVED ANY FURTHER INFORMATION FROM THE PATIENT OR FAMILY AT IT WAS ASSUMED THAT THE PREVIOUSLY MENTION REPROGRAMMING DONE OVER THE PHONE WAS EFFECTIVE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS NOTED THAT THE PATIENT HAD BEEN REPROGRAMMED ONCE BEFORE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS LEAKING CONSTANTLY. THE PATIENT WOULD THINK THEY WERE DONE USING THE BATHROOM AND WOULD WIPE AND FELT THAT THEY HAD LEAKED AGAIN. IT WAS NOTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS SINCE 6 MONTHS AGO. IT WAS MENTIONED THAT THE PATIENT FELL 3 WEEKS AGO. IT WAS REPORTED THAT THE PATIENT LAST FELT STIMULATION ABOUT A YEAR AGO WHEN THE MANUFACTURER REPRESENTATIVE HELPED WITH STIMULATION ADJUSTMENT. STIMULATION WAS INCREASED ON PROGRAM 1 FROM 3.60V TO 5.30C=V AND THE PATIENT WAS IN DISCOMFORT ABOVE 5.30V. IT WAS NOTED THAT THEY WOULD MONITOR THE PATIENT¿S SYMPTOMS AND SEE IF THE HEALTH CARE PROVIDER (HCP) WAS NECESSARY. THE LAST TIME THE PATIENT HAD GONE BACK TO SEE THEIR HCP WAS WHEN THEY HAD A URINARY TRACT INFECTION AND THEY COULDN¿T ADJUST STIMULATION A FEW MONTHS AFTER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135939 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |