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

Model Number 37603

Device Problem Break (1069)

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37085-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: extension.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.

Event Description

Information was received from a patient via a manufacturing representative with an implantable neurostimulator (ins) for dystonia movement disorders.It was reported that the patient had a broken extension which was confirmed by an x-ray.The extension is broken on their right side above their ear.The patient reported that their head is pounding and their chest is burning.They further reported that their neck and ins site hurt, and they can feel the wire pulling.Additionally, the patient stated that they have blood vessels popping out on the left and right, along with their shoulder and neck spassing.A manufacturing representative helped the patient turn their device off.The patient is waiting for insurance to clear the revision of the broken extension.No complications or further complications were reported.The issues were reported to have begun a couple months prior.

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; 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6417531
• MDR Text Key: 70350826
• Report Number: 3004209178-2017-05929
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

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: 03/14/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 09/14/2011
• 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
• Patient Age: 41 YR