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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MFG; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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RICE CREEK MFG; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 748951
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturing representative (rep) regarding a patient.The rep reported that they were calling from the operating room and indicated that the extension is not torquing down on the leads.They stated that the healthcare provider tried tightening it, but nothing happened.Technical services verified the instructions.The rep stated that they had to end the call to grab another extension from their car.No further complications or patient symptoms were reported or anticipated.
 
Event Description
Information was received from a manufacturing representative (rep) regarding a patient.The rep reported that they were calling from the operating room and indicated that the extension is not torqueing down on the leads.They stated that the healthcare provider tried tightening it, but nothing happened.Technical services verified the instructions.The rep stated that they had to end the call to grab another extension from their car.No further complications or patient symptoms were reported or anticipated.2020-feb-26 snow rtg0021404, _e1, snow rtg0021416 (rep, hcp): additional information was received via a manufacturer representative from a health care professional.It was reported that the implantable neurostimulator as being replaced due to normal end of service.The patient had old quad lead extensions that needed be removed so that they could replace with new extensions.The physician had trouble backing out the set screws in the old extensions.Additionally, it was noted that the wrench that they were trying to use was too large to fit in the setscrews.The physician remembered that that he had used ¿bone wax¿ years ago over the extension set screws and that is why he had difficulty removing the old extension.Once he cleared out the wax, he was able to successfully back out the set screws and replace the extension and complete the implantable neurostimulator replacement.No extra extension needed to be opened.There were no patient symptoms or complications reported.
 
Manufacturer Narrative
Concomitant medical products: product id 748951 lot# serial# (b)(6) implanted: (b)(6) 2003 explanted: product type extension 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.
 
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Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432 1200
MDR Report Key9813599
MDR Text Key189766238
Report Number3007566237-2020-00316
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/17/2007
Device Model Number748951
Device Catalogue Number748951
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
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