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  

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.

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.

• 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: 12862637
• MDR Text Key: 288034425
• Report Number: 3004209178-2021-17514
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Date Device Manufactured: 01/04/2019
• 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 Sex: Female