SURESCAN
Report
- Report Number
- 3007566237-2016-04594
- Event Type
- Injury
- Date Received
- December 29, 2016
- Report Date
- February 6, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- GZB
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. 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.
MFT SITE ID WAS CHANGED FROM 3007566237 TO 3004209178. MFG SITE ID WAS UPDATED ON JANUARY 25, 2017. FORGOT TO NOTE THAT UPDATE IN THE SUPPLEMENTAL REPORT SUBMITTED ON JANUARY 25, 2017.
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.
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.
CONCOMITANT PRODUCTS: PRODUCT ID: 3887-33, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3887-33, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THERE WAS A LEAD ISSUE. THE REP NOTED THAT HE WAS PREPPING FOR A LEAD REVISION. THE REP STATED THAT HE READ IN THE N LINK NOTES THAT THE PATIENT WAS NOT GETTING GOOD COVERAGE, CHARGED A LOT MORE OFTEN, AND HAD SOME HIGH IMPEDANCES. THE REP ALSO NOTED THAT THIS WAS THE PATIENT'S 3RD REVISION. IT WAS NOTED THAT THE REP DID NOT HAVE THE PATIENT INFORMATION AS THE REPS SYSTEM WAS DOWN. IT WAS UNKNOWN IF THE PATIENT RECOVERED COMPLETELY. THE REP NOTED THAT HE WAS JUST READING THE N LINK NOTES TODAY, BUT HE BELIEVED THEY WERE ENTERED THE WEEK PRIOR.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THE "REVISION" WAS ACTUALLY A REPLACEMENT OF THE PATIENT'S ENTIRE SYSTEM. THE INS, TWO LEADS AND TWO EXTENSIONS WERE EXPLANTED ON (B)(6) 2016 AND WERE REPLACED WITH A NEW INS AND A LEAD. THE CAUSE OF THE HIGH IMPEDANCES, LACK OF GOOD COVERAGE AND NEED TO RECHARGE LONGER WERE MOST LIKELY DUE TO THE EXTENSIONS OR THE LEADS. THEY COULD NOT BE CERTAIN SINCE EVERYTHING WAS EXPLANTED BUT THEY WERE CERTAIN IT WAS NOT THE INS BECAUSE AN INTRA-OPERATIVE IMPEDANCE CHECK WAS PERFORMED WHEN THE EXTENSIONS WERE STILL ATTACHED. THEY STATED THEY DO NOT BELIEVE THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE HIGH IMPEDANCES DID RESOLVE AFTER THE REPLACEMENT SURGERY, AND THEY BELIEVE THE LACK OF ADEQUATE COVERAGE AND NEED TO RECHARGER LONGER WERE ALSO RESOLVED BECAUSE THEY HAD NOT HEARD FROM THE PATIENT NOR COULD FIND ANY NOTES ON THE PATIENT. REGARDING THE PRIOR REVISIONS MENTIONED IN THE ORIGINAL CALL, THEY CONFIRMED THEY WERE NOT REFERRING TO PRIOR REVISIONS BUT RATHER MEANT PRIOR DEVICE REPLACEMENTS. THEY HAD NO KNOWLEDGE OF THE REASON FOR THE PRIOR DEVICE REPLACEMENTS AND THE PATIENT HAD NOT MENTIONED ANY DEVICE OR THERAPY CONCERNS PERTAINING TO THOSE PRIOR DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863461 | SURESCAN | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | GZB | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |