MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem High impedance (1291)

Patient Problems Fall (1848); Muscle Weakness (1967); Visual Impairment (2138)

Event Type  Injury  

Event Description

It was reported on (b)(6) 2014 that there were some out of range impedances on the right side.The measurement of unipolar 4 was 6,600 ohms, 5 was 2,400, and 6 was 2,100.The impedances were not tested at a higher setting.The patient needed a mri for possible neurological issues.The patient was seen in september or october by his healthcare provider (hcp) and at the time he was getting great therapeutic benefit.Three to five days later the patient started to have vision lapses, which lasted a few seconds, and occurred every few hours.The patient also started to experience a loss of muscle tone in his legs after visiting the hcp, describing it as ¿giving out.¿ this occurred a few times a day.The patient was seen by other physicians and they ruled out seizures.In december the patient¿s implantable neurostimulator (ins) was turned off completely and remained off at the time of the report.The patient still had some vision differences and his legs still gave out, but he was not falling as often.The reporter noted that the patient would be having a battery replacement due to it being near end of life (eol) from normal depletion.Five days later it was reported that the patient was doing fine and he was scheduled for a battery replacement ¿in a few weeks.¿ the following day it was reported that there were out of range impedances on the left side.However, it was noted that typical numbering suggested the impedances were for the right side.Thus, it was unclear which side had out of range impedances.

Manufacturer Narrative

Concomitant products: product id 748266, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7428, serial # (b)(4), implanted: (b)(6) 2007, product type implantable neurostimulator; product id 7436, serial # (b)(4), product type programmer, patient; product id 748266, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3389s-40, lot # v023165, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v024801, implanted: (b)(6) 2007, product type lead; product id 64002, lot # n268789, implanted: (b)(6) 2011, product type adapter; product id 3389s-40, lot # v063950, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient.(b)(4).

Event Description

Additional information received reported that the patient was having the battery change out on the day of the report due to normal battery depletion.The patient had not had the implantable neurostimulator (ins) turned on for the past six months due to side effects.Since having the ins off, the patient continued to experience decreased muscle tone and vision, so he was scheduled for a mri.The physician did not think the symptoms were device related, but did not know what was causing them.It was noted that the right side ins impedances were slightly higher than normal.Combination case and 4, 4 and 6, and 4 and 7 were showing 3,900 to 4,300 ohms.The previous impedances on these combinations on (b)(6) 2014 were 6,600, 7,876, and 7,406 ohms respectively.On (b)(6) 2014 the impedances were 3,923, 3,574, and mid-4,000 to 5,000 ohms respectively.The ins was not going to be turned on after replacement as the patient was going to see the neurologist for programming.Four days later it was reported that everything went well after troubleshooting.The patient was doing fine.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3830756
• MDR Text Key: 16549457
• Report Number: 3004209178-2014-09587
• Device Sequence Number: 1
• Product Code: MHY
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2014
• Date Device Manufactured: 03/14/2011
• 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