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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problems Low impedance; Impedance Problem
Event Date 11/24/2014
Event Type  Injury  
Event Description

It was reported that there was a tingling following a battery replacement. The patient started having numbness on one side of his face including the lips 2 weeks prior to the report. The symptoms were worse in the morning but would subside if the patient pressed on the implant with his hand. Imaging was performed and impedances were checked and nothing abnormal was found. Additional information received one month later reported there was a shocking sensation at the implantable neurostimulator (ins) pocket site and a stroke symptom at the right arm. It was a gradual change in therapy/symptoms. Towards the end of the device in (b)(6) 2015, the patient felt stroke symptoms at the right side of the arm. They turned the stimulation off. When the patient received their last implant in (b)(6) 2014, that is when he noticed a strange feeling initially (not shocking) and he had reprogramming sessions; however, it kept getting worse. When the patient would turn the stimulation on in the mornings, his lips would go numb for about a minute and then it would subside. He had the same experience with the first implant. The month prior to report whenever he reached he felt shocking on the whole right side of his body. There were intermittent impedances. Impedances would change with positional changes. The patient had a replacement done in (b)(6) 2015 for normal battery replacement. When they replaced the ins and extension, they both tested well. The new ins was working with no issues. The ins replacement resolved the shocking issue. No trauma or falls were reported and there were no unrelated medical procedures. The patient recovered completely.

 
Manufacturer Narrative

Concomitant products: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v140982, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v134483, implanted: (b)(6) 2008, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id: 3550-29, product type: accessory. Product id: 64002, product type: adapter. Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

 
Event Description

Additional information received from a manufacturing representative reported the patient's health care provider (hcp) was getting different impedances readings based on position. The implantable neurostimulator (ins) was replaced due to normal battery depletion with no complications. The patient was doing fine. There was no patient death or injury and they had recovered without sequela.

 
Manufacturer Narrative

Updated.

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no significant anomaly. The ins was functionally okay with insignificant anomalies. Analysis of the adaptor found the conductor on the adaptor body had a short between circuits (dry conditions). The conductors were kinked/twisted in the adapter body and were beginning to fray 4. 9 cm from the proximal end. Individual filer was seen protruding through the insulation.

 
Manufacturer Narrative

(b)(4). No longer applies to this event and was removed.

 
Event Description

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Event Description

Additional information was received: it was reported that the patient reported their ins implanted on (b)(6) 2019 "shorted out" in just a matter of a few weeks and they started to get a shock from it. The patient said it occurred shortly after the implant and was at least able to clarify that it started happening "a few weeks after the implant, so roughly around (b)(6) 2014. There were no further complications reported.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, 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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263920
MDR Report Key4919122
Report Number3004209178-2015-13528
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/17/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2015 Patient Sequence Number: 1
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