INTERSTIM II
Report
- Report Number
- 3004209178-2012-07851
- Event Type
- Injury
- Date Received
- September 6, 2012
- Report Date
- August 9, 2012
- 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
PRODUCT ID 3889-28, LOT# V251861, SERIAL#, IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3037, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2012 THE PATIENT HAD AN EKG DONE BY A PRIMARY CARE PHYSICIAN AND HAD FORGOT TO TURN THE DEVICE OFF, LEADING TO A FALSE EKG READING. THE PATIENT THEN NOTICED PROBLEMS WITH THE BATTERY IN (B)(6) 2012. IT WAS ALSO REPORTED THAT "SINCE THE EKG" THE PATIENT HAD NOTICED THE INS BATTERY DEPLETING RAPIDLY. THE PATIENT'S SYMPTOMS HAD FIRST RETURNED (B)(6) 2012 AND HAD BEEN GETTING WORSE. INFORMATION PREVIOUSLY REPORTED REGARDING A URINARY TRACT INFECTION (UTI) UNDER THIS MANUFACTURER REPORT # WAS ALSO REPORTED IN MFR. REP. #3004209178-2012-08886. ADDITIONAL INFORMATION RECEIVED REGARDING THE UTI WILL BE CONDUCTED UNDER MFR. REP. #3004209178-2012-08886.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE INFECTION AROUND THE SURGICAL SCAR FROM THE PATIENT'S LAST BATTERY IMPLANT HAD "CLEARED" FOLLOWING TREATMENT WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE PATIENT STILL HAD LEAKAGE AND WEARS PADS; HOWEVER, IT WAS REPORTED THAT THE PATIENT LEAKED MORE BEFORE IMPLANT. THE DEVICE WAS IMPLANTED FOR OVERACTIVE BLADDER (OAB) AND FREQUENCY. THE REPORTER STATED THAT THE PATIENT DOES NOT FULLY EMPTY OUT AND THAT SHE CAN USUALLY GO THROUGH THE NIGHT WHEREAS BEFORE THE IMPLANT SHE WOULD GO 3-4 TIMES IN THE NIGHT. THE PATIENT WAS UP TWICE TO USE THE BATHROOM ON THE NIGHT BEFORE (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT'S STIM LEVEL WAS 8.5V AND THAT HER BATTERY WAS LOW. IT WAS NOTED THAT THE BATTERY WAS DEPLETED AND THAT THE PROGRAMMER "SAYS" THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS VERY LOW. THE PATIENT WAS ADVISED TO SPEAK WITH THE HEALTH CARE PROFESSIONAL (HCP) ABOUT POTENTIAL PROGRAM CHANGES. IT WAS NOTED THAT THE PATIENT HAD ONLY WORKED WITH THE PHYSICIAN'S PHYSICIAN ASSISTANT (PA). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION ON (B)(6) 2012, BUT THERE WAS NO DEVICE PROBLEM. THE PATIENT WAS STILL HAVING CONCERNS, BUT HAD NOT SOUGHT HELP AS SHE HAD TO GET A CYSTOURETHROGRAM DONE. THE PATIENT STATED THAT AFTER THE MESH WAS FIXED HER HCP WOULD GET HER DEVICES WORKING CORRECTLY.
IT WAS REPORTED THAT WHEN THE PATIENT WAS IN THE OPERATING ROOM DURING HER DEVICE REPLACEMENT IN (B)(6) 2011 SHE NOTICED SHE WASN'T FEELING STIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE IN (B)(6) 2012. THE HCP PROVIDED HER WITH ANTIBIOTICS AND THEY HELPED. IT WAS NOTED THAT THE PATIENT TOOK BLOOD PRESSURE MEDICATION, AS WELL AS PAIN MEDICATION FOR HER NECK AND BACK. SHE USUALLY GOT PAIN INJECTIONS (PROTEIN INJECTIONS FOR HER RIGHT AND LEFT SIDE) TO HELP WITH HER NECK AND BACK BUT THE HCP WANTED TO HOLD OFF ON ADMINISTERING THEM UNTIL THE INFECTION HEALED UP. IT WAS ALSO REPORTED THAT THE HCP TRIED "MOVING HER LEADS" AND SINCE THEN THE PATIENT HAD FELT A SLIGHT PAIN THAT LASTED A FEW SECONDS AND THEN WENT AWAY. THERE WAS NO REASON THIS OCCURRED, IT JUST HAPPENED RANDOMLY. IT WAS UNCLEAR IF "MOVING HER LEADS" MEANT A LEAD REVISION, OR REFERRED TO REPROGRAMMING. THE PATIENT STATED THAT HER THERAPY WAS HELPING HER SYMPTOMS OF URINARY INCONTINENCE, BUT SHE STILL HAD SOME LEAKING. SHE TRIED ALL THE OTHER PROGRAMS ON HER PROGRAMMER BUT THEY GAVE HER THE SAME EFFECT. SHE WENT IN FOR REPROGRAMMING IN (B)(6) OR (B)(6) OF 2012, AND AFTER SHE WAS REPROGRAMMED IT HELPED WITH HER SHAKING. IT WAS REPORTED THAT THE PATIENT THOUGHT HER INS WAS GETTING LOW AND NEEDED TO BE REPLACED, AS THE INS ICON ON HER PROGRAMMER WAS ONLY 1/4TH FULL. THE PATIENT HAD JUST HAD A REPLACEMENT IN (B)(6) OF 2011, HOWEVER HER STIMULATION WAS AT 8.5V. THE PATIENT ALSO STATED THAT SOMETIMES HER STIMULATION WAS EVEN HIGHER THAN 8.5V. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |