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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 28-oct-2020, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 08-dec-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the caller states the patient had a revision because the patient's ins was 'not working properly' and 'malfunctioned, stopped working'.The caller didn't know the exact details but ultimately the ins was replaced.Caller was concerned that the op note said that the excess lead was coiled behind the ins.
 
Manufacturer Narrative
Note that the h6 codes have been updated to reflect the new information continuation of d10: product id: 977a260, serial# (b)(6), product type: lead; product id: 977a260, serial# (b)(6), product type: lead.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.
 
Event Description
Additional information was received from the healthcare provider (hcp).The battery would not recharge.The device was unable to be interrogated.The cause of the ins not working properly was the battery was not recharging.The hcp clarified that leads coiled is standard procedure to place leads when there is excess length.The actions/interventions taken to resolve the ins not working was the generator was replaced on (b)(6) 2019.The issues were resolved with the battery replacement.Mdr decision for pli 30 and 40 updated to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.
 
Manufacturer Narrative
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.
 
Event Description
Additional information was received from the healthcare provider (hcp).The battery would not recharge.The device was unable to be interrogated.The cause of the ins not working properly was the battery was not recharging.The hcp clarified that leads coiled is standard procedure to place leads when there is excess length.The actions/interventions taken to resolve the ins not working was the generator was replaced on (b)(6) 2019.The issues were resolved with the battery replacement.Mdr decision for pli 30 and 40 updated to not reportable.No additional supplemental reports are required unless additional infor mation received indicates reportable event.
 
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Brand Name
SURESCAN
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key12225380
MDR Text Key263407747
Report Number3004209178-2021-11379
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109483
UDI-Public00643169109483
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight113
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