MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems High impedance (1291); Low impedance (2285); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_unknown_ext, serial/lot #: unknown.Product id: 64002, serial/lot #: (b)(4), ubd: 03/26/2022, 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 (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia.High impedances were measured on c/0 - 3664 ohms, c/1 - 3008 ohms and c/4 - 2724 ohms prior to ins replacement; the ins was at elective replacement indicator (eri).The ins and adaptor were replaced during the procedure.Immediately after replacement, there was high impedance on c/2 - 2418 ohms, but the previously mentioned contacts were in normal range between 800 and 1600 ohms.A measurement later in the day noted that impedance was still high at 2117 ohms on c/2, and bipolar pair 4/7 was low.A couple hours later, pair c/2 had normalized, but pairs 0/1, 4/7, 5/7, and 4/5 were low.The following day, the previously mentioned low impedance pairs had normalized in the range of 800 to 1600 ohms, but pair 1/2 was low.It was noted that no bipolar pair was used in programming.Therapeutic impedance decreased from 1117 and 739 ohms (left and right, respectively) to 484 and 557 ohms over the course of the day of replacement and increased to 597 ohms on the left and decreased to 512 ohms on the right the next day.It was noted that ins settings were different at each time that therapy impedance was measured.It was also noted that the medical team was considering explanting the device.The patient was reported to be unstable, although no specific symptoms were reported.

Manufacturer Narrative

Product id 748295; serial# (b)(4).Product type extension; product id 748295; serial# (b)(4).Product type extension; product id 64002; lot# 0216670438.Product type adapter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported that the patient's extensions were explanted due to an impedance failure with random results.It was unknown if there were any external factors that led to the event.It was reported that the issue was resolved at the time of the event; however, it was previously stated the issue had not been resolved, so the patient outcome is not clear.Follow-up will be performed to clarify this information.

Manufacturer Narrative

Month and year of below implant dates are known, but exact date is not known.Product id 748295; serial# (b)(4), implanted: (b)(6) 2008.Product type extension; product id 748295; serial# (b)(4); implanted: (b)(6) 2008.Product type extension; product id 64002; lot# 0216670438 explanted: (b)(6) 2019.Product type adapter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified that the impedances were better at this time.

Manufacturer Narrative

Product id 748295, serial# (b)(4), implanted: (b)(6) 2008.Product type: extension.Note that extension (b)(4) was initially reported, but additional information indicates this is incorrect and (b)(4) is the correct serial number.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information (including product return) has been received which has confirmed that (b)(4) was mistakenly reported.(b)(4) is the correct extension, and it was returned to medtronic for analysis.Product id 748295, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type: extension.Product id 748295, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type extension.Product id 64002, lot# 0216670438; explanted: (b)(6) 2019.Product type adapter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 748295, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type extension.Product id 748295, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type extension, product id 64002, lot# 0216670438, explanted: (b)(6) 2019.Product type adapter.The returned extensions (serial nos: (b)(4)) were subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The extensions were returned segmented; there was no impact to electrical functionality.The returned adaptor (lot no: 0216670438) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #1 and #4 conductors were broken in the body of the adaptor within 10 cm of the connector area.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8907605
• MDR Text Key: 154831259
• Report Number: 9614453-2019-02781
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2019

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: 09/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/22/2019; 09/20/2019; 11/13/2019; 12/03/2019; 12/16/2019
• Supplement Dates FDA Received: 09/10/2019; 10/03/2019; 11/25/2019; 12/05/2019; 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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