MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problem Noise, Audible (3273)

Patient Problems Muscle Spasm(s) (1966); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.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

A healthcare provider (hcp) reported a consumer with a very complicated medical history of wilsons¿s disease, nutritional disorder, primary torsion dystonia, acquired torsion dystonia, chronic pain, cerebral palsy, constipation, disorder of gi tract, spastic paresis, neuralgia, seizures, vomiting, diarrhea, elevated liver enzymes, and mitochondrial metabolism defect.The consumer¿s recent history included gi issues including mucousy stools, bloating, and vomiting.The consumer was positive for c.Diff in (b)(6) of 2016.In (b)(6) of 2016 they were admitted to the hospital with aspiration pneumonia, vomiting, and fever, and were discharged on (b)(6) 2016.It was noted the consumer experienced chronic pain and a five pound weight loss was noted in (b)(6) of 2016.On (b)(6) 2016 the dbs battery was alarming so an attempt was made to schedule a battery replacement.On (b)(6) 2016 the consumer once again experienced vomiting and a low grade fever, and was readmitted to the hospital on (b)(6) 2016 with concerns about their gallbladder.Due to the issues the dbs battery replacement surgery was put on hold.On (b)(6) 2016 the vomiting continued, but a gallbladder issue was ruled out.Instead the consumer was diagnosed with pneumonia and a bowel obstruction.On (b)(6) 2016 their g-tube was removed and replaced with a j-tube.The consumer was discharged on (b)(6) 2016, but was readmitted to the hospital on (b)(6) 2016 for vomiting; the dbs battery replacement remained on hold.On (b)(6) 2016 hospice and comfort care was discussed, but the family wasn¿t ready to make this decision.By (b)(6) 2016 the consumer was having seizures again and their muscle contractions were worsening.Documentation from (b)(6) 2016 showed the consumer weighed (b)(6).As of (b)(6) 2016 the consumer was receiving hospice care at home as their bowels had failed and they had lost more than 20 pounds.Due to health issues all follow-up appointments were cancelled as the family was unable to travel with them anymore.A later reported noted the consumer died as of (b)(6) 2016, but it wasn¿t thought to be related to the device, but rather due to a ¿complicated progressive diagnosis which led to multiple complications associated with it.¿ relevant medical history includes dystonia and movement disorders.

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 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6064623
• MDR Text Key: 58699116
• Report Number: 3004209178-2016-22816
• Device Sequence Number: 1
• Product Code: MRU
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2016
• Date Device Manufactured: 12/11/2014
• 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): Other
• Patient Age: 20 YR