MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

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 health care provider (hcp) reported via a manufacturer representative that the patient was not able to charge the implantable neurostimulator (ins) more than 50 percent with continuous charging.The patient's dystonia had gotten worse and the ins battery was stinging pain at the back of it.The stinging pain worsened when the patient charged the ins, but it was there all of the time.The patient also had occasional jerks which are a sharper pain, that were not described as electric shocks.The hcp thought the ins needed replacing, but the ins had only been implanted for one year.The patient was currently hospitalized.The patient was implanted with a four lead system for deep brain stimulation (dbs).Impedances were checked on (b)(6) 2017 and they were measured to be within normal range.The ins battery was at 50 percent charged.The ins was programmed to c+, 1-, 2- at 1.3 v, 450 usec, and 125 hz on lead 1 of the left side, c+, 5-, 6- at 2.1 v, 450 usec, and 125 hz on the lead 2 of the left side, c+, 9-, 10- at 2.1v, 450 usec, a nd 125 hz on the lead 1 of the right side and 14-, 15+ at 2.1v, 300 usec, and 125 hz on lead 2 of the right side.The ins was checked again on (b)(6) 2017 and impedances were normal and the ins battery was at 25 percent charged.No changes had been made to the ins programming.No power on reset messages were displayed on the recharger and the patient did not have a patient programmer.The patient reported they had been charging the ins every day, but it was taking longer to charge.The patient had not noticed the ins symbol being off, but when the hcp checked the ins it was off.Since then, the patient had not been able to charge past 50 percent after charging for hours.The was scheduled for imaging on (b)(6) 2017.The hcp indicated there was a possibility that the ins would be replaced on (b)(6) 2017 due to the possibility of the ins being flipped.Recharge statistics showed that several recharging sessions were initiated on (b)(6) 2017.The ins was not charging and there was zero average coupling.No further patient complications were reported.The patient's indication for use is dystonia.

Manufacturer Narrative

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

Additional information received from a manufacturer representative reported the implantable neurostimulator (ins) was found not to be flipped.A revision was done and the ins was explanted and replaced.

Manufacturer Narrative

Analysis identified that the implantable neurostimulator (ins) is functioning within specifications but has reduced capacity due to overdischarge.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6571758
• MDR Text Key: 75323988
• Report Number: 3004209178-2017-10440
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

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: 12/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: Not provided; 11/30/2017; 01/05/2018
• Supplement Dates FDA Received: 05/18/2017; 12/06/2017; 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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): Hospitalization; Required Intervention