MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37603

Device Problems High impedance (1291); Low impedance (2285); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.Concomitant medical products: other relevant device(s) are: product id: 3708640, serial/lot #: (b)(4), ubd: 08-apr-2019, udi#: (b)(4); product id: 3708640, serial/lot #: (b)(4), ubd: 08-apr-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had bilateral implantable neurostimulator (ins) replacement due to elective replacement indicator (eri).Upon interrogation, that was the first notice that the right ins had high impedance at contact 3 (6k).Also, the left ins had a short/low impedance at bipolar pair 1-3 only, and high impedance at contact 0 for all monopolar and bipolar pairs (12k for both mono and bipolar pairs).The cause is unknown.The doctor said that at the last ins change, the extensions were very twisted at the ins site.The doctor suspects the patient may have "twiddle" but has not confirmed.The doctor was not aware of any falls that they feel may have contributed to the impedance issue on both sides.The doctor reviewed all programmed settings and since neither the left nor right settings are using the contact pairs with the impedance issue, the doctor chose not to change the extensions at this time.They did inspect the extensions as close as possible near the ins site and did not see any signs of visible issues.The impedance issue did not resolve after the right ins replacement, which now showed 7k.For the left ins, with a bit of gently untwisting the extension and then inserting into the new ins, the short at bipolar pair 1-3 was now within normal limits.The high impedance at contact 0 for all mono and bipolar pairs remained the same (high at 12k).The issue was considered as resolved.Refer to manufacturer report #3004209178-2021-17514, #3004209178-2021-17515 for related device.

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.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 12862662
• MDR Text Key: 281161894
• Report Number: 3004209178-2021-17516
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384340
• UDI-Public: 00763000384340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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 Date: 02/14/2023
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/23/2021
• Date Device Manufactured: 08/20/2021
• 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
• Treatment: "SEE H10...."
• Patient Sex: Female