INTERSTIM II
Report
- Report Number
- 3004209178-2013-07416
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 10, 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4).
(B)(4).
ANALYSIS OF THE DEVICE, MODEL # 3058, SN (B)(4), FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, MODEL # 3093-33, LOT # V498896, FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, MODEL # 3093-33, LOT # V326265, FOUND NO SIGNIFICANT ANOMALY.
PRODUCT ID 3093-33, LOT # V498896, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # V326265, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION ((B)(4) 2010).
(B)(4). ADDITIONAL REVIEW INDICATED THAT THE PATIENT¿S OTHER DEVICE WAS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010) AND THIS DEVICE SHOULD NOT HAVE BEEN INCLUDED IN THE NOTIFICATION. NOTIFICATION SHOULD NOT HAVE BEEN CHECKED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE DOCTOR REMOVED THE LEADS AND IMPLANTABLE NEUROSTIMULATORS, AND SOME OF ONE LEAD WAS LEFT BEHIND. IT WAS NOTED THAT THE DOCTOR WOULD LIKE TO KNOW WHAT WAS LEFT FROM THE LEAD. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.
IT WAS REPORTED THAT A LEAD WAS DAMAGED DURING EXPLANT. IT WAS BELIEVED THAT THE PHYSICIAN WAS REMOVING ALL COMPONENTS DUE TO PAIN BUT THE REPORTER WAS UNSURE OF EXACT REASON. THE HCP REMOVED THE LEAD FROM POCKET. IT APPEARED VISUALLY ALL TINES AND DISTAL ELECTRODES WERE LEFT IN PATIENT, BUT IT WAS HARD TO TELL . THE PATIENT HAD BI-LATERAL INTERSTIMS (2 3058 <(>&<)> 2 LEADS PLACED). IT WAS BELIEVED THE LEFT SIDE LEAD WAS THE LEAD DAMAGED DURING EXPLANT. ADDITIONAL INFORMATION RECEIVED NOTED THAT THERE WERE NO DIAGNOSTICS PERFORMED. REGARDING MALFUNCTIONS SEEN OR CAUSE OF ISSUE DETERMINED IT WAS NOTED "NO." REGARDING WERE ALL COMPONENTS FULLY EXPLANTED IT WAS NOTED "NO." THE SERIAL NUMBER OF THE DAMAGED LEAD WAS UNKNOWN. REGARDING DAMAGE DONE TO THE LEAD DURING EXPLANT IT WAS NOTED THAT THE ELECTRODE PORTION WAS LEFT BEHIND. REGARDING HOW THE DAMAGE WAS CAUSED IT WAS NOTED THAT THE DOCTOR PULLED THE LEAD FROM THE POCKET AND THE LEAD BROKE DURING REMOVAL. REGARDING THE PATIENT OUTCOME IT WAS NOTED THAT THE PATIENT WAS FINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL REVIEW INDICATED THAT THE DAMAGED LEAD AND THE ELECTRODES LEFT IN THE PATIENT WERE NOT RELATED TO THIS DEVICE AND WERE RELATED TO THE PATIENT'S OTHER DEVICE. SEE MFR. REPORT #3004209178-2013-07417.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203268 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Required Intervention |