MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7427

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Skin Inflammation/ Irritation (4545); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2005

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3998; lot# (b)(4); implanted: (b)(6) 2005; product type: lead.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 02-feb-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for postlaminectomy pain.It was reported that when the patient was first implanted therapy was great but when he got home he got very sick and was coughing and vomiting.Patient states that original implanting hcp believes those symptoms were related to lead position as it had migrated.Troubleshooting was not required.The troubleshooting steps that were taken on the call resolved the issue. caller states during a full system replacement for a natural battery depletion and improperly seated lead (rtg0192246) when hcp made incision over ins they noticed a chalky substance and inquired if it could be leakage from the ins.Troubleshooting was not required.The issue was not resolved through troubleshooting.Ts reviewed that casing is made out of titanium and we are not familiar with cases where casing has leaked.Caller confirmed that ins casing did not appear to be punctured or damaged.Advised caller to send ins in for analysis.Swabs were also taken by hcp and sent to pathology.Hcp planned to do a staged trial and implant ins on thursday.

Manufacturer Narrative

Continuation of d10: product id: 748940, serial# (b)(6), implanted: (b)(6) 2005, explanted: (b)(6) 2021, product type: extension; product id: 748940, serial# (b)(6), implanted: (b)(6) 2005, explanted: (b)(6) 2021, product type: extension; product id: 3998, lot# j0511388v, implanted: (b)(6) 2005, explanted: (b)(6) 2021, product type: lead.H3.Analysis of the implantable neurostimulator (ins) (b)(6) found that the ins was functionally okay with insignificant anomalies.H6: the conclusion code d14 no longer applies.The results code c20 no longer applies.The method code b20 no longer applies.H3.Analysis of the lead j0511388v found the lead body was cut through/product segmented/no significant anomaly and/or explant damage.H6: the conclusion code d14 no longer applies.The results code c20 no longer applies.The method code b17 no longer applies.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.

Manufacturer Narrative

H3.Analysis of the implantable neurostimulator (ins) (b)(6) found that the ins was functionally okay with insignificant anomalies.The major component of the white substance is calcium phosphate.Protein was detected and carbonate might also be present.The fm is likely the result of calcification occurred on the device.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.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12212246
• MDR Text Key: 262977460
• Report Number: 3004209178-2021-11280
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2006
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 04/14/2022; 04/14/2022
• Supplement Dates FDA Received: 04/14/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male