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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 977D260
Device Problems Break (1069); Difficult to Remove (1528); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2020
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 manufacturer¿s representative (rep) regarding a trial patient.The rep reported that the lead was damaged during a trial procedure.The physician performing the procedure attempted epidural access and lead placement but was unable to advance the lead.The rep reported that instead of removing the needle, he attempted to remove the lead through the need and damaged the lead.The lead was not reattempted.The lead was clearly damaged and would be returned.The rep reported that the patient was not injured and 2 leads were effectively placed for his trial.No further complications were reported.
 
Manufacturer Narrative
H3.Analysis found that the distal end of the lead and stylet wire are bent at approximately 0.7 centimeters from the distal end.H6.Evaluation conclusion code 11 does not apply.Evaluation method code 4118 does not apply.Evaluation result code 3233 does not apply.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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Brand Name
SURESCAN
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9879269
MDR Text Key184900953
Report Number2649622-2020-06194
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00763000006570
UDI-Public00763000006570
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
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/26/2023
Device Model Number977D260
Device Catalogue Number977D260
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/16/2020
Initial Date FDA Received03/25/2020
Supplement Dates Manufacturer Received06/19/2020
Supplement Dates FDA Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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