MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Battery Problem (2885); Charging Problem (2892)

Patient Problems Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system, other applicable components are: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: extension.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2016, product type: extension.

Event Description

Information was received from a health care provider (hcp)via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the implantable neurostimulator (ins) battery was draining prematurely causing more frequent recharging intervals, a return of symptoms, and shocking when conducting routine impedances checks; the shocking was noted to not be at the pocket site.It was also confirmed that there was no falls related to the issue.Troubleshooting included x-rays and an impedance check performed by the hcp at an unknown date.The manufacturer representative (rep) also performed an impedance check on (b)(6) 2016 and resulted in low impedances on c <(>&<)>2, c<(>&<)>3, and 2<(>&<)>3.Therapy contacts on the left resulted in 756 ohms while the right was 734 ohms.It was also reported that the extension was removed as the insulation was broken that caused the wires to be exposed; the issues were resolved.It is unknown when the issues began occurring.

Manufacturer Narrative

Analysis of the extension (s/n (b)(4)) found the extension body was cut through and product was segmented 59.2cm from the proximal end along with the outer insulation of the extension body was melted.Analysis of the extension (s/n (b)(4)) found the conductor of the extension body was broken (overstress/damage) where the outer insulation, all conductors, and coil were cut 7.9cm from the proximal end and the extension body was stretched where 2 conductors pulled through the outer insulaton.

Event Description

Additional information received reported that the product would be returned on (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5785406
• MDR Text Key: 49277665
• Report Number: 3004209178-2016-13993
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2016

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: 01/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; 07/17/2016
• Supplement Dates FDA Received: 08/09/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2011
• 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